MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-08 for CONTROLLER, VEST 105C manufactured by .
[5037310]
Hill-rom received a report from the account stating the vest power cord will spark when the device is plugged in. The vest was located at the account. There was no patient/user injury reported. This report was filed in our complaint handling system as complaint #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12447188]
Hill-rom technical support found the power cord to be inoperable. A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed. It is unknown if the facility performs preventative maintenance on their beds. Hill-rom technical support sent the account a new power cord to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008145987-2014-00009 |
| MDR Report Key | 4210303 |
| Report Source | 06 |
| Date Received | 2014-08-08 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-07-24 |
| Date Mfgr Received | 2014-07-24 |
| Date Added to Maude | 2014-10-31 |
| 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 | JOHN CUMMINGS |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312869 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTROLLER, VEST |
| Generic Name | THE VEST |
| Product Code | BYI |
| Date Received | 2014-08-08 |
| Model Number | 105C |
| 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 | 2014-08-08 |