MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-22 for VEST AIR PULSE GENERATOR P300413000 manufactured by Hill-rom Singapore.
[26683666]
Hill-rom sent a replacement power cord. It is necessary for the vest? Airway clearance system to have an effective maintenance program. We recommend that you do annual preventive maintenance. The power cord is with the unit, and it is in good condition: the plug is a one-piece molded plug assembly, the assembly shows no signs of cracking, the plug molding around the blade is not discolored, and the blade is tight in the molding. A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this unit. It is unknown if the account performs preventative maintenance on this unit. The account will replace the power cord to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[26683667]
Hill-rom received a report from the account stating the power cord sparked and left a burn mark on the end of the cord. The unit was located in the patients home. 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
| Report Number | 3008145987-2015-00002 |
| MDR Report Key | 5093721 |
| Date Received | 2015-09-22 |
| Date of Report | 2015-08-31 |
| Date of Event | 2015-08-31 |
| Date Mfgr Received | 2015-08-31 |
| Date Added to Maude | 2015-09-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 0 |
| Brand Name | VEST AIR PULSE GENERATOR |
| Generic Name | THE VEST |
| Product Code | BYI |
| Date Received | 2015-09-22 |
| Model Number | P300413000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM SINGAPORE |
| Manufacturer Address | 1 YISHUN AVENUE 7 SINGAPORE, NORTH EAST 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-22 |