Bed, Ac-Powered Adjustable Hospital
FDA adverse event reports and recall history for bed, ac-powered adjustable hospital (product code FNL), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 93,396
- Deaths
- 645
- Injuries
- 1,856
- Malfunctions
- 89,126
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-06-04Open, ClassifiedDevice Design
Pediatric care bed; Product Designation: KayserBett IDA;
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even death of the patient (child) or third parties (children).
- 2024-10-25Open, ClassifiedSoftware design
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P7900B100277, P7900B100307, P7900B000010, P7900B100017, P7900B100026, P7900B100222, P7900B100281, P7900B1SPL05, P7900B000011, P7900B100018, P7900B100028, P7900B100223, P7900B100287, P7900B1SPL06, P7900B000020, P7900B100019, P7900B100039, P7900B100224, P7900B100288, P7900B000022, P7900B100020, P7900B100090, P7900B100231, P7900B100292, P7900B100001, P7900B100021, P7900B100161, P7900B100237, P7900B100293, P7900B100005, P7900B100022, P7900B100203, P7900B100242, P7900B100294, P7900B100009, P7900B100023, P7900B100205, P7900B100264, and P7900B100296. b. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900A000001, P7900A000010, P7900A000019, P7900A000039, P7900A000005, P7900A000011, P7900A000022, and P7900A000063.
The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through the nurse call system.
- 2023-12-22Open, ClassifiedDevice Design
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
Unintended movement of bed wheels
- 2023-12-22Open, ClassifiedDevice Design
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
Unintended movement of bed wheels
- 2023-12-01Open, ClassifiedProcess control
ProCuity bed series, model number 3009, item number: 300900000000,
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
- 2023-12-01Open, ClassifiedProcess control
ProCuity bed series, model number 3009, item number: 3009PX-L-100.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
- 2023-12-01Open, ClassifiedProcess control
ProCuity bed series, model number 3009, item number: 3009PX-L-200
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
- 2023-12-01Open, ClassifiedProcess control
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
- 2023-12-01Open, ClassifiedProcess control
ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
- 2023-12-01Open, ClassifiedProcess control
ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Monitor bed, ac-powered adjustable hospital automatically
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