MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-01 for PERRY SIGMA II manufactured by Perry Baromedical.
[2687650]
During the ascent of our last hyperbaric o2 treatment, it was noted that the chamber was ascending slower than normal. The dive was completed with no ill effects to the pt. After the dive was completed, the chamber mfr (perry baromedical) was called and told of the problem. Their tech, (b)(4) called us back and instructed us on how to adjust the needle valve control knot to increase the rate of ascent of the chamber. The rate adjustment was tested during 5 more timed dives of the chamber. The next morning ((b)(6) 2012) the chamber was tested again with compression and decompression rates falling within the mfrs spec's. (b)(4) (perry's tech) was on the phone during the testing and approved the use of the chamber. (b)(6), was informed of the situation with the chamber. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025262 |
| MDR Report Key | 2561447 |
| Date Received | 2012-05-01 |
| Date of Report | 2012-04-25 |
| Date of Event | 2012-04-12 |
| Date Added to Maude | 2012-05-08 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| 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 | PERRY SIGMA II |
| Generic Name | HYPERBARIC OXYGEN CHAMBER |
| Product Code | CBF |
| Date Received | 2012-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERRY BAROMEDICAL |
| Manufacturer Address | 3660 INTERSTATE PKWY RIVIERA BEACH FL 33404 US 33404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-01 |