MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-02-18 for HYPERBARIC CHAMBER 3200R manufactured by Sechrist Industries, Inc..
[18411679]
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.
Patient Sequence No: 1, Text Type: D, B5
[18688259]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2011-00002 |
| MDR Report Key | 2036715 |
| Report Source | 06 |
| Date Received | 2011-02-18 |
| Date of Report | 2011-02-17 |
| Date of Event | 2011-01-28 |
| Date Facility Aware | 2011-01-31 |
| Date Mfgr Received | 2011-01-31 |
| Device Manufacturer Date | 2004-09-29 |
| Date Added to Maude | 2012-02-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 4225 EAST LA PALMA AVE. |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer Phone | 7145798400 |
| Manufacturer G1 | SECHRIST INDUSTRIES, INC. |
| Manufacturer Street | 4225 EAST LA PALMA AVE. |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92807 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYPERBARIC CHAMBER |
| Generic Name | 32 IN PNMTC, REVRS |
| Product Code | CBF |
| Date Received | 2011-02-18 |
| Model Number | 3200R |
| Catalog Number | 3200R |
| Lot Number | NA |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | ANAHEIM CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-18 |