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..
[82139375]
Patient Sequence No: 1, Text Type: N, H10
[82139376]
Received call from mother of patient stating that the ipv device was not working properly. Attempted to troubleshoot equipment over the phone with no resolution. Scheduled home visit and arrived at patient's home to find ipv working for 2-3 minutes but started to slow down. Equipment replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6776515 |
| MDR Report Key | 6776515 |
| Date Received | 2017-08-09 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-07-28 |
| Report Date | 2017-08-04 |
| Date Reported to FDA | 2017-08-04 |
| Date Reported to Mfgr | 2017-08-04 |
| 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 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| 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 |