MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-08-08 for HYPERBARIC CHAMBER 2500B/BR manufactured by Sechrist Industries, Inc..
[51483155]
Sechrist made several attempts to try and obtain the chamber for evaluation. Several phone calls were made to dr. (b)(6) at (b)(6) and messages were never returned. Based on device history review, this chamber was in use beyond the current pvho regulated cylinder life of 20 years and was manufactured in 1989. This hyperbaric chamber was originally sold to (b)(6) hospital and sechrist conducted annual preventative maintenance through 1998. At no time was sechrist made aware of relocation of this chamber to any other facility. (b)(6) fire investigation stated that dr. (b)(6) purchased the chamber on (b)(6). Based on (b)(6) fire investigations sechrist industries also learned that dr. (b)(6) placed a battery operated fan in the chamber while in use. Introduction of any type of heat source into a hyperbaric chamber is strictly against manufacturer recommendations as well as nfpa99 health care facilities code, chapter 14 hyperbaric facilities. : device not provided for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[51483156]
Sechrist industries received an email from (b)(6) with (b)(6) news stating that they would be airing a story about a fire that took place inside a hyperbaric chamber at (b)(6). Reportedly, (b)(6) brought her dog to the veterinarian clinic where dr. (b)(6) gave the dog oxygen therapy by putting the dog inside a hyperbaric chamber. During therapy the chamber caught on fire, killing the dog.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020676-2016-00005 |
| MDR Report Key | 5855494 |
| Report Source | OTHER |
| Date Received | 2016-08-08 |
| Date of Report | 2016-03-15 |
| Date of Event | 2015-08-22 |
| Date Mfgr Received | 2016-03-15 |
| Date Added to Maude | 2016-08-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. VICTOR ARELLANO |
| Manufacturer Street | 4225 E. LA PALMA AVENUE |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer Phone | 7145798400 |
| Manufacturer G1 | SECHRIST INDUSTRIES, INC. |
| Manufacturer Street | 4225 E. LA PALMA AVENUE |
| 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 | 0 |
| Brand Name | HYPERBARIC CHAMBER |
| Generic Name | HYPERBARIC CHAMBER |
| Product Code | CBF |
| Date Received | 2016-08-08 |
| Model Number | 2500B/BR |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | 4225 E. LA PALMA AVENUE ANAHEIM CA 92807 US 92807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-08-08 |