MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-04-19 for IVC BARIATRIC BED 9153641598 NA:BAR600IVC manufactured by Invacare Florida.
[73228306]
The device has been returned and an evaluation is in process. A follow-up report will be filed when the evaluation is complete. A replacement has been sent.
Patient Sequence No: 1, Text Type: N, H10
[73228307]
The provider reported the end user could see the sparks coming from under the bed, they called their attendant and had the bed unplugged. When the provider went to home he noticed the plug to the pendant melted.
Patient Sequence No: 1, Text Type: D, B5
[74393773]
The product was received for evaluation and the complaint of the control box sparking and emitting smoke was confirmed. The c1 capacitor shorted out causing the failure. There was evident discoloration and deformation around the d-sub 9 pin female pendant connector due to the heat source being applied from the capacitor failure. The control box housing is comprised of v0 rated material and will self-extinguish once the heat source is removed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1031452-2017-00039 |
| MDR Report Key | 6503549 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-04-19 |
| Date of Report | 2017-03-21 |
| Date of Event | 2017-03-20 |
| Date Mfgr Received | 2017-04-27 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2017-04-19 |
| 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 | IVC BARIATRIC BED 9153641598 |
| Generic Name | BARIATRIC BED |
| Product Code | OSI |
| Date Received | 2017-04-19 |
| Model Number | NA:BAR600IVC |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-04-19 |