MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-07-06 for IVC BARIATRIC BED 9153641598 NA:BAR600IVC BAR600IVC manufactured by Invacare Florida.
[79175401]
The bed has been returned and an evaluation is in process. The facility states that the bed started smoking while the patient was in the bed, so they unplugged it. They left the patient in the bed. There were no injuries or damage caused by the bed. The bed has been replaced. When the return evaluation has been completed, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[79175402]
The dealer stated according to his customer, the junction box on the bed caught on fire. Nothing was damaged and no one was injured.
Patient Sequence No: 1, Text Type: D, B5
[83321052]
An evaluation of the returned bed has been completed. The testing of the junction box confirmed that two capacitors shorted out, which caused smoke to emit from the box when pressing the head up/down functions on the pendant. This issue has been escalated to our risk department. Should further information be identified, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1031452-2017-00049 |
| MDR Report Key | 6690145 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-07-06 |
| Date of Report | 2017-06-08 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-08-09 |
| Device Manufacturer Date | 2017-01-01 |
| Date Added to Maude | 2017-07-06 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | AC POWERED BED |
| Product Code | OSI |
| Date Received | 2017-07-06 |
| Returned To Mfg | 2017-06-20 |
| Model Number | NA:BAR600IVC |
| Catalog Number | BAR600IVC |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-07-06 |