MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-18 for PAHI HBO CHAMBER * manufactured by Pan-america Hyperbarics Inc.
[21412295]
Pt was treated for diabetic foot ulcer. Pt's 25th treatment with history of sinus congestion. The door latch dislodged, resulting in sudden decompression of the chamber. Pt c/o complained of light headedness and ear tenderness. Staff notified vendor about the incident and pan-america hyperbarics inc responded with a site visit within 24 hours. Pahi replaced the outer steel latch handle and ultimately replaced the entire door latch of this chamber and the other hyperbaric oxygen chamber. ======================manufacturer response for hyperbaric oxygen chamber, pahi hbo chamber======================manufacturer fixed the door.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2075477 |
| MDR Report Key | 2075477 |
| Date Received | 2011-04-18 |
| Date of Report | 2011-04-18 |
| Date of Event | 2010-12-01 |
| Report Date | 2011-04-18 |
| Date Reported to FDA | 2011-04-18 |
| Date Added to Maude | 2011-05-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAHI HBO CHAMBER |
| Generic Name | HYPERBARIC OXYGEN CHAMBER |
| Product Code | CBF |
| Date Received | 2011-04-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PAN-AMERICA HYPERBARICS INC |
| Manufacturer Address | 525 INTERNATIONAL PARKWAY SUITE 507 RICHARDSON TX 75081 US 75081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-18 |