FDA Adverse Event
Malfunction
Summary report: N
RECOVERAIRE
MDR report key: 3811805
·
Received May 9, 2014
Report
- Report Number
- MW5036076
- Event Type
- Malfunction
- Date Received
- May 9, 2014
- Date of Event
- April 28, 2014
- Report Date
- May 8, 2014
- Manufacturer
- RECOVERCARE
- Product Code
- IOQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
WHILE PROVIDING CARE TO THE PATIENT, IT WAS NOTICED THAT THE BED TUBING HAD BECOME PULLED TIGHT IN THE SIDE RAIL CAUSING THE WIRES TO FRAY LEADING TO SPARKS COMING FROM THE LOWER END OF THE BED. FIRE ALARM PULL STATION WAS PULLED. 9-1-1 WAS CALLED AND THE FIRE DEPARTMENT ARRIVED. NO INJURY TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281371 | RECOVERAIRE | LOW AIR LOSS SPECIALTY MATTRESS | IOQ | RECOVERCARE | VCEOTE (3000 ELITE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |