DRIVEMEDICAL 13606Recalls & reported problems
Drive Devilbiss Healthcare · Patient RoomPatient alarms Product Description: Patient Alarm,Bed,1/ea · Class 1
All models of DRIVEMEDICAL (111)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383116327), received between Mar 14, 2022 and Mar 14, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “No Audible Alarm” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- No Audible Alarm1
Patient problems
- Fall1
- Head Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2022No Audible Alarm; No Audible Alarm
ON (B)(6) 2022, DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT REGARDING A PRESSURE-SENSITIVE CHAIR AND BED PATIENT ALARM, INTENDED TO ALERT A CAREGIVER WHEN A PATIENT GETS OUT OF A CHAIR OR BED. THE PATIENT'S DAUGHTER REPORTED THAT HER MOTHER, A DEMENTIA PATIENT, GOT OUT OF BED TWICE WITHIN HOURS OF EACH OTHER AND THAT THE ALARM FAILED TO FUNCTION BOTH TIMES, RESULTING IN HER MOTHER FALLING TWICE. IN THE SECOND FALL, THE PATIENT HIT HER HEAD "BUT SHE IS OK," AND NO MEDICAL ATTENTION WAS SOUGHT. THE REPORTER INDICATED THAT THE DEVICE WAS PLUGGED IN TO OUTLET POWER, CONCLUDING THAT IT WAS "NOT A BATTERY ISSUE." DRIVE DEVILBISS IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO INSPECT IT.
Patient problems: Fall; Head Injury
MAUDE report 13760280 ↗
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- NaviCare® Patient Safety Systems 3.9Hill-Rom, Inc. · MONITOR, BED PATIENT1 recall0 reports
- Cubby Beds KIT10001Sensory Medical, Inc. · Monitor, Bed Patient30 reports
- Medline MDT8450YMedline Industries, Inc. · MONITOR, BED PATIENT29 reports
- POSEY 8309ELPosey Products, LLC · Monitor, Bed Patient2 deaths19 reports
- POSEY 8399Posey Products, LLC · Monitor, Bed Patient19 reports
- POSEY 8645WLPosey Products, LLC · Monitor, Bed Patient17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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