MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-03-15 for IVC BARIATRIC BED 9153641598 NA:BAR600IVC BAR600IVC manufactured by Invacare Taylor St..
[69970819]
The motors, junction box and pendant were returned. The bed frame was not returned. An evaluation of the components has not been completed at this time, therefore the cause of the fire could not be determined. The dealer stated the bed was set up in the facility and has been in operation until the alleged event. The bed is 11 years old. The dealer has not ordered a replacement. Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[69970820]
The tbm called stated the bed had a fire. The tbm stated no property damage no injury. There was a patient in the bed when the event happened but was not hurt.
Patient Sequence No: 1, Text Type: D, B5
[73304202]
The following components were returned for an expanded evaluation: 6 function control box, 6 way hand pendant, foot motor, hi/lo motor and head motor. The complaint was confirmed for the failed control box. The reported issued of a fire could not be duplicated as the control box was not functionally tested due to the received condition. There was discoloration and deformation consistent with heat or smoke damage near the hi/lo and bed molex motor connectors. The control box housing is comprised of v0 rated material and will self-extinguish once the heat source is removed. The root cause can be attributed to a capacitor failure. The control box was dated for september 6, 2005. The product is approximately 12 years old which is well beyond its end of life. An event review request has been submitted to address this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1031452-2017-00034 |
| MDR Report Key | 6405751 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-03-15 |
| Date of Report | 2017-02-13 |
| Date Mfgr Received | 2017-04-12 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2017-03-15 |
| 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 TAYLOR ST. |
| Manufacturer Street | 1200 TAYLOR ST. |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44036 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVC BARIATRIC BED 9153641598 |
| Generic Name | BED, BARIATRIC |
| Product Code | OSI |
| Date Received | 2017-03-15 |
| Returned To Mfg | 2017-03-14 |
| Model Number | NA:BAR600IVC |
| Catalog Number | BAR600IVC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE TAYLOR ST. |
| Manufacturer Address | 1200 TAYLOR STREET ELYRIA OH 44036 US 44036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-15 |