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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERRY BAROMEDICAL PERRY SIGMA II HYPERBARIC OXYGEN CHAMBER

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PERRY BAROMEDICAL PERRY SIGMA II HYPERBARIC OXYGEN CHAMBER Back to Search Results
Event Date 04/12/2012
Event Type  Malfunction  
Event Description

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).

 
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Brand NamePERRY SIGMA II
Type of DeviceHYPERBARIC OXYGEN CHAMBER
Manufacturer (Section D)
PERRY BAROMEDICAL
3660 interstate pkwy
riviera beach FL 33404
MDR Report Key2561447
Report NumberMW5025262
Device Sequence Number1
Product CodeCBF
Report Source Voluntary
Reporter Occupation RESPIRATORY THERAPIST
Type of Report Initial
Report Date 04/25/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 05/01/2012 Patient Sequence Number: 1
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