MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-07 for FLUIDAIR ELITE manufactured by Arjohuntleigh Inc..
[94109614]
Patient Sequence No: 1, Text Type: N, H10
[94109615]
The power cord of bed was run over by some sort of cart that sliced into the power cord causing the wires to spark and temporarily catching the wires on fire. This involved a hospital cart/machine and a hospital employee. The employee was though to be part of the respiratory department, and possibly some type of respiratory equipment like a ventilator was involved. The patient was never on the bed and it was swapped before the patient needed it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7094931 |
| MDR Report Key | 7094931 |
| Date Received | 2017-12-07 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-11-21 |
| Report Date | 2017-12-05 |
| Date Reported to FDA | 2017-12-05 |
| Date Reported to Mfgr | 2017-12-05 |
| Date Added to Maude | 2017-12-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLUIDAIR ELITE |
| Generic Name | BED, AIR FLUIDIZED |
| Product Code | INX |
| Date Received | 2017-12-07 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH INC. |
| Manufacturer Address | YVONNE MCMANN 12625 WETMORE ROAD SUITE 308 SAN ANTONIO TX 78247 US 78247 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-07 |