MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-07-25 for IVC BARIATRIC BED 9153641598 NA:BAR600IVC BAR600IVC manufactured by Invacare Florida.
[80960830]
The junction box of the bed was returned and the results of an evaluation is pending. Attempts to get additional information at this time have been unsuccessful. There was no injury or property damage alleged with this event. This record is being filed in an abundance of caution due to the allegation of the unit smoking. When the evaluation results become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[80960831]
Customer alleged that the junction box he just is defective. He had it on the bed and while operating the hilo function the bottom of the junction box blew out and you can see the brass piece inside. When you hit the hilo button, smoke comes from the junction box. He tried plugging the hilo motor into another port on the box and confirmed the motor works fine, the issue is with the hilo port on the junction box.
Patient Sequence No: 1, Text Type: D, B5
[118620158]
An evaluation of the returned junction box has been completed. The testing of the junction box confirmed that a capacitor shorted out causing no output when the bed up/down functions were pushed on the pendant. The heat coming off of the capacitor damaged the housing of the control box. The facility has been given a replacement junction box. The replacement has been installed and the bed works as it should with no further issues. Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1031452-2017-00051 |
| MDR Report Key | 6741934 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-07-25 |
| Date of Report | 2017-06-27 |
| Date Mfgr Received | 2017-08-09 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2017-07-25 |
| 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 | 2017-07-25 |
| Returned To Mfg | 2017-07-05 |
| 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 | 2017-07-25 |