MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-07-03 for CONTROLLER, VEST 105 P105CM manufactured by Singapore North East.
[18001424]
The patient reported to hill-rom that the vest control unit was smoking. The unit was located at the patient's home. The patient reported that he did inhale a small amount of smoke but did not report any injuries. The vest itself did not smoke, the control unit did. He was able to move the control unit outside onto his porch. This report was filed in our complaint handling system as (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18319869]
The vest control unit was returned and evaluated. Hill-rom engineering found that a power failure caused damage to the blower, generator and main control board. 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 | 3008145987-2014-00008 |
| MDR Report Key | 4001949 |
| Report Source | 04,07 |
| Date Received | 2014-07-03 |
| Date of Report | 2014-06-06 |
| Date of Event | 2014-06-06 |
| Date Mfgr Received | 2014-06-06 |
| Date Added to Maude | 2014-08-20 |
| 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 | 2014-07-03 |
| Model Number | P105CM |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SINGAPORE NORTH EAST |
| Manufacturer Address | SINGAPORE 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-03 |