MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-16 for MONOPLACE HYPERBARIC CAHMBER 32" 3200 manufactured by Sechrist Industries, Inc..
[2983186]
The hyperbaric technician was compressing the chamber to 3 ata at rate of 1. 5 psi/min during a scheduled testing. When the chamber reached 2. 5 ata the technician heard a loud pop and gas escaping form the chamber. Then the chamber rapidly decompressed. The technician shut off the gas supply to the chamber. An initial observation was completed by the hyperbaric technician and reported to the manufacturer. The door handle had moved 90 degrees toward the open position. The swing arm did not move beyond the open position and held the door in place. The door gasket was blown out of place and crumpled in the limited space between the door and swing arm. Immediately after the incident the chamber was taken out of service. The chamber was evaluated and photographed by a representative of the manufacturer, who went to the customer's facility, (b)(4) 2012. During the evaluation a loaner hyperbaric chamber was installed so that this chamber could be sent back to the manufacturer and tested.
Patient Sequence No: 1, Text Type: D, B5
[10259123]
The hyperbaric chamber was overhauled by the manufacturer in (b)(4) 2012. The device has been received by the manufacturer for evaluation. The team evaluating the device is gathering information before proceeding with the investigation. A plan of action for the evaluation is being put together before the chamber is tested and touched.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2012-00050 |
| MDR Report Key | 2857513 |
| Report Source | 06 |
| Date Received | 2012-11-16 |
| Date of Report | 2012-11-16 |
| Date of Event | 2012-10-18 |
| Date Mfgr Received | 2012-10-18 |
| Device Manufacturer Date | 1995-09-28 |
| Date Added to Maude | 2013-02-25 |
| 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 | 3 |
| 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 | MONOPLACE HYPERBARIC CAHMBER 32" |
| Generic Name | HYPERBARIC CHAMBER 32" |
| Product Code | CBF |
| Date Received | 2012-11-16 |
| Model Number | 3200 |
| Catalog Number | 3200 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-11-16 |