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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. HYPERBARIC CHAMBER 32 IN PNMTC, REVRS

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SECHRIST INDUSTRIES, INC. HYPERBARIC CHAMBER 32 IN PNMTC, REVRS Back to Search Results
Model Number 3200R
Event Date 01/28/2011
Event Type  Malfunction  
Event Description

The pt was being treated for chronic osteomyelitis. The pt is diabetic, however, his diabetes is controlled. This was his 62nd treatment, five days of treatments with two off for the weekend. He had not missed any treatments to date as of (b)(6) 2011. After the incident on the 28th, his treatments stopped. The treatments were week to week as long as he continued to show healing and improvement in the wound. Each week, the progress would be reassessed to see if treatments should continue. There was an order for another 30 treatments after his initial 60. Wound care treatments were being performed by an outside doctor, a podiatrist, not a doctor affiliated with the wound care center at the hospital. This pt is the third of the day for his hyperbaric chamber. The pt's vitals and blood sugar were taken prior to treatment since he is diabetic. These readings are taken before and after each treatment. The vitals were normal before the treatment. Blood sugar was normal for him which is usually higher, in the range of 200. The treatment is for a pressure of 2. 5ata at a rate of 2psi. Pt is at pressure for 90 minutes with 2-5 minutes air breaks. Air breaks are after 30 minutes of oxygen. Typically it takes 11 minutes to get to pressure. The 11 minutes is within normal timeframes for this chamber. Pt notified attendant of the blindness after he came out of the chamber. The doctor was called and an assessment was performed. Blood pressure was high at this time, however, did come down after resting (doctor's observation). Per the attendant, this may have been high as he was anxious about his vision. Some of the pt's vision started to come back prior to his going to the eye specialists. Approx 1. 5 hours after the treatment, pt saw the eye specialist. He was evaluated by both an ophthalmologist and an optometrist. The doctor who was there for the hbo treatment discussed the situation with the eye doctors. Hospital reported that there are no adverse problems with him having to stop his hyperbaric treatments.

 
Manufacturer Narrative

The device was functionally tested and found to meet its approved specification. No findings were noted that would indicate the device contributed to the effects reported.

 
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Brand NameHYPERBARIC CHAMBER
Type of Device32 IN PNMTC, REVRS
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
anaheim CA
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC.
4225 east la palma ave.
anaheim CA 92807
Manufacturer Contact
4225 east la palma ave.
anaheim , CA 92807
7145798400
MDR Report Key2036715
Report Number2020676-2011-00002
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 02/17/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/18/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL Number3200R
Device Catalogue Number3200R
Is The Reporter A Health Professional? No
Distributor Facility Aware Date01/31/2011
Date Manufacturer Received01/31/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/29/2004
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/18/2011 Patient Sequence Number: 1
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