MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-11-05 for CONTROLLER, VEST 105 P105 manufactured by .
[19800266]
The pt's mother contacted hill-rom and stated that the device sparked and started to smell like smoke. The device was located in the pt's home. There was no pt/user injury reported. This report was filed in our complaint handling system as complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19914090]
The hill-rom tech found visual indication of electrical arching on the internal iec power inlet fuse holder. There was evidence of fluid on the iec power inlet module and fuse holder and this was most likely the cause for the arching and burning smell. The tech could not duplicate the problem because the fluid had dried. The device had no abnormal error code and the device powered on normally and ran a complete therapy session without issue. Based on this info, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008145987-2014-00010 |
| MDR Report Key | 4254733 |
| Report Source | 04,07 |
| Date Received | 2014-11-05 |
| Date of Report | 2014-10-07 |
| Date of Event | 2014-10-07 |
| Date Mfgr Received | 2014-10-07 |
| Date Added to Maude | 2014-11-19 |
| 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 FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TONY WERNER |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312359 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTROLLER, VEST 105 |
| Generic Name | THE VEST |
| Product Code | BYI |
| Date Received | 2014-11-05 |
| Model Number | P105 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-05 |