D
Patient 1
DURING SCHEDULED TESTING THE TECH NOTED THAT THE CHAMBER IS COMPRESSING OUTSIDE OF MFR SPECIFICATIONS. SET AT A RATE OF 1, THE CHAMBER IS COMPRESSING AT 1 PSI PER 43 SECONDS. THIS RATE IS FASTER THAN THE SPECIFIED RATE.
MAUDE MDR 2854339
- MDR report key
- 2854339
- Report number
- 2020676-2012-00051
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-10-24
- Date received
- 2012-11-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Address
- 4225 EAST LA PALMA AVE. ANAHEIM CA 92807 US
- Phone
- 714-714-7145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CHAMBER, HYPERBARIC | HYPERBARIC MONOPLACE CHAMBER | SECHRIST INDUSTRIES, INC. | CBF | 3200R | 3200R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-11-28 | 0 |
Event Narratives#
N
Patient 1
THE CHAMBER HAD PREVIOUSLY RECEIVED ITS ANNUAL SERVICE MAINTENANCE ON (B)(4) 2012. NO ISSUES REGARDING THE FUNCTIONALITY WERE NOTED ON THE REPORT. EVALUATION OF THE CHAMBER VERIFIED THE REPORTED FAILURE. AT A RATE OF 1 THE CHAMBER WAS COMPRESSING 1PSI PER 44 SECONDS. THE RATE VALVE WAS REPLACED AND THE CHAMBER WAS PERFORMANCE VERIFIED. IT WAS FOUND TO FUNCTION PER FACTORY SPECIFICATION. A REQUEST FOR THE ORIGINAL RATE VALVE HAS BEEN MADE. AN UPDATE WILL BE SENT UPON EVAL OF THE RATE VALVE.