MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-05-08 for IVC BARIATRIC BED 9153641598 NA:BAR600IVC BAR600IVC manufactured by Invacare Florida.
[144472763]
The head motor assembly, and the bariatric foot section were returned to invacare. The complaint was confirmed during an evaluation. It was determined that the 6-function control box emitted smoke and produced sparks when the head down function operated. Based on the location of where the sparks and smoke were produced and after reviewing the engineering drawing for the 6-function pcb, it was determined that the cause the of the failure was a direct short to capacitor c1 of the 6-function control box. It was determined that the failure was contained to the 6-function control box, and there was no malfunction or defect to the head motor. A replacement bar5490ivc foot section, was sent to the dealer for servicing of the bed, the control box date code, july 13, 2016, falls outside the scope of recalls z-2399/2402-2016 and z-1182/1185-2017. However, the returned control box was manufactured prior to a design change to implement a new capacitor, ico-157061, which was implemented on february 10, 2017. Since launch of this design change, there have been no failures. Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[144472764]
The end user alleged that they smelled a burning smell and saw smoke coming from the foot section of the bar600ivc bed. There were no injuries alleged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031452-2019-00011 |
| MDR Report Key | 8592666 |
| Report Source | OTHER |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-12 |
| Date Mfgr Received | 2019-04-12 |
| Device Manufacturer Date | 2017-01-01 |
| Date Added to Maude | 2019-05-08 |
| 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 |
| 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 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| 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 | IVC BARIATRIC BED 9153641598 |
| Generic Name | BARIATRIC BED |
| Product Code | OSI |
| Date Received | 2019-05-08 |
| Model Number | NA:BAR600IVC |
| Catalog Number | BAR600IVC |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-08 |