MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-28 for BAR600IVC, BAR6640IVC, BARMATT42 9153647355 NA:BARPKGIVC-1633 BARPKGIVC-1633 manufactured by Invacare Florida.
[93562923]
The dealer provided a loaner bed for the end user and a new replacement bed has been ordered. At this time, the underlying cause of the failure cannot be determined. Invacare has received the head and foot section of the bed; an expanded evaluation is pending. Once the evaluation has been completed, a supplement record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[93562924]
The caller is stating that his bed made a loud pop noise. Then, electrical smoke filled the house and there was a flash of sparks. The callers son came into the room, removed the mattress and unplugged the unit. The family called the fire department to make sure there was no hidden fire or other damage. The bed was plugged into a surge protector.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031452-2017-00061 |
| MDR Report Key | 7064778 |
| Report Source | CONSUMER |
| Date Received | 2017-11-28 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-10-24 |
| Date Mfgr Received | 2017-10-31 |
| Device Manufacturer Date | 2015-08-01 |
| Date Added to Maude | 2017-11-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE FLORIDA |
| Manufacturer Street | 2101 EAST LAKE MARY BLVD |
| Manufacturer City | SANFORD FL 32773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAR600IVC, BAR6640IVC, BARMATT42 9153647355 |
| Generic Name | AC POWERED BED |
| Product Code | OSI |
| Date Received | 2017-11-28 |
| Returned To Mfg | 2017-11-15 |
| Model Number | NA:BARPKGIVC-1633 |
| Catalog Number | BARPKGIVC-1633 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE FLORIDA |
| Manufacturer Address | 2101 EAST LAKE MARY BLVD SANFORD FL 32773 US 32773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-28 |