MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-19 for PERCUSSIONAIRE F00012-HT S00009 manufactured by Percussionaire Corp..
[90753345]
The ipv hc is a homecare therapy device for airway clearance. The suspect device was returned to the distributor's biomed technician, who completed the investigation. The device was investigated and functional tested with no issues noted, and subsequently returned into service. During the technician's investigation, no evidence of heat or smoke was found on or in the device. The only anomolies noted were that the gray outer layer of the power cord insulation was shifted, and exposed a bit more of the inner wires' insulation than typical, though the insulation on the inner wires was intact, with no copper wires showing. Also, the fan grills were missing, and the filter cap was missing. This was not a reportable event, but we decided to file this mdr so that our response to the end user's report would be on record.
Patient Sequence No: 1, Text Type: N, H10
[90753346]
Home health nurse reported that the device was hot and smoking, and that the wires on the unit's connector were frayed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000524541-2017-00004 |
| MDR Report Key | 6962415 |
| Date Received | 2017-10-19 |
| Date of Report | 2017-10-02 |
| Date of Event | 2017-07-24 |
| Date Mfgr Received | 2017-08-16 |
| Device Manufacturer Date | 2015-05-07 |
| Date Added to Maude | 2017-10-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHAWN BURNS |
| Manufacturer Street | 1655 GLENGARY BAY RD. |
| Manufacturer City | SAGLE ID 83860 |
| Manufacturer Country | US |
| Manufacturer Postal | 83860 |
| Manufacturer Phone | 2082632549 |
| Manufacturer G1 | PERCUSSIONAIRE CORP. |
| Manufacturer Street | 1655 GLENGARY BAY RD. |
| Manufacturer City | SAGLE ID 83860 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 83860 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PERCUSSIONAIRE |
| Generic Name | IPV HC |
| Product Code | NHJ |
| Date Received | 2017-10-19 |
| Model Number | F00012-HT |
| Catalog Number | S00009 |
| Operator | HOME HEALTH AIDE |
| Device Availability | N |
| 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 | 2017-10-19 |