MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-11-20 for CONTROLLER VEST 105 P105 manufactured by .
[21084446]
Hill-rom received a report from the account stating the control unit was smoking. The unit 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
[21219789]
The control unit was sent back for evaluation. The unit was evaluated and d8 was found to have expired. The investigation is ongoing, however, if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008145987-2014-00011 |
| MDR Report Key | 4286558 |
| Report Source | 07 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-10-21 |
| Date of Event | 2014-10-21 |
| Date Mfgr Received | 2014-10-21 |
| Date Added to Maude | 2014-12-02 |
| 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 |
| 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 | 2014-11-20 |
| Model Number | P105 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-20 |