MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-07 for PERCUSSIONAIRE F00012-HT S00009 manufactured by Percussionaire Corp..
[90107097]
The ipv hc is a homecare therapy device for airway clearance. The suspect device was returned to the hospital's biomed technician, who completed the investigation. The device was investigated and functional tested to manufacturer's specifications with no issues noted, and subsequently returned into service. 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. For further details.
Patient Sequence No: 1, Text Type: N, H10
[90107098]
Initial reporter indicated that device was not working properly, and would shut down after a few minutes of use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000524541-2017-00003 |
| MDR Report Key | 6926606 |
| Date Received | 2017-10-07 |
| Date of Report | 2017-10-02 |
| Date of Event | 2017-07-28 |
| Date Mfgr Received | 2017-08-16 |
| Device Manufacturer Date | 2015-06-29 |
| Date Added to Maude | 2017-10-07 |
| 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 | 2017-10-07 |
| Model Number | F00012-HT |
| Catalog Number | S00009 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 2017-10-07 |