MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-09 for IPV PERCUSSIONATOR FAMILY AND ACC manufactured by Percussionaire Corp.
[82140019]
Patient Sequence No: 1, Text Type: N, H10
[82140020]
The home health nurse noticed that the ipv unit was hot and smoking. The unit was stopped immediately and unplugged. The equipment was cleaned, tested and replaced. Frayed wires on the unit's connector was identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6776565 |
| MDR Report Key | 6776565 |
| Date Received | 2017-08-09 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-07-24 |
| Report Date | 2017-07-31 |
| Date Reported to FDA | 2017-07-31 |
| Date Reported to Mfgr | 2017-07-31 |
| Date Added to Maude | 2017-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IPV PERCUSSIONATOR FAMILY AND ACC |
| Generic Name | DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT |
| Product Code | NHJ |
| Date Received | 2017-08-09 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERCUSSIONAIRE CORP |
| Manufacturer Address | 1655 GLENGARY BAY RD SAGLE ID 83860 US 83860 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-09 |