MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-24 for IPV MACHINE F00012 manufactured by Percussionaire Corporation.
[18256524]
Client is cared for at home and has a tracheostomy and ventilator. His care includes the use of an ipv (intrapulmonary percussive ventilator) every 4 hrs along with the administration of ventolin and hypertonic saline to be given with the ipv. Upon attempt to administer treatment, client was found to immediately desaturate per his continuous pulse oximeter. The machine was immediately removed and the dme company (pro o2) that supplies the machine was contacted to fix the machine. It is possible that an incorrect part was placed on the machine (one way valve instead of a flapper valve) which created the increasing pressure in the client? S lungs. Dates of use: (b)(6) 2012 and (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027384 |
| MDR Report Key | 2809445 |
| Date Received | 2012-10-24 |
| Date of Report | 2012-10-15 |
| Date of Event | 2012-10-09 |
| Date Added to Maude | 2012-11-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IPV MACHINE |
| Generic Name | IPV MACHINE |
| Product Code | NHJ |
| Date Received | 2012-10-24 |
| Model Number | F00012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERCUSSIONAIRE CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-24 |