MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2018-09-06 for HYPERBARIC CHAMBER manufactured by Sechrist Industries.
[119480997]
Hospital instructed that chamber be taken out of service. On (b)(6) 2018, the hospital assigned an independent technician (b)(6) with (b)(4) to inspect the chamber and the chamber was found to meet specification. On august 27, 2018 (b)(4) with sechrist industries, the chamber was tested and performed to manufacturer specifications. A dhr (device history record) review was performed. The chamber, serial number (b)(4), was manufactured on 07/01/2011. There is no indication that there were any relevant discrepancies during manufacturing. A review of the device history record (dhr) found no nonconformance that could cause or contribute to the reported issue.
Patient Sequence No: 1, Text Type: N, H10
[119480998]
It was reported that patient expired post treatment of hbot (hyperbaric oxygen therapy). Patient was receiving his 14th hbot treatment of 110 minutes and was being treated for a diabetic foot ulcer. Technician operating the chamber noticed the patient was unresponsive and was removed from the chamber, with no respiration post treatment and cpr was initiated by staff. Aed was untilized without shocks being given. Ems responded within 5 minutes and conducted a full code for 50 minutes before patient was pronounced dead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020676-2018-00015 |
| MDR Report Key | 7853825 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-09-06 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2018-09-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MAJID MASHAYEKH |
| Manufacturer Street | 4225 E. LA PALMA |
| Manufacturer City | ANAHEIM 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer G1 | SECHRIST INDUSTRIES |
| Manufacturer Street | 4225 E. LA PALMA |
| Manufacturer City | ANAHEIM 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 | HYPERBARIC CHAMBER |
| Product Code | CBF |
| Date Received | 2018-09-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES |
| Manufacturer Address | 4225 E. LA PALMA AVENUE ANAHEIM CA 92807 US 92807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-09-06 |