MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-18 for BARA-MED N/A manufactured by Environmental Tectonics Corp..
[57734475]
Patient Sequence No: 1, Text Type: N, H10
[57734476]
When the technician went to close the door to the chamber and begin the patient's treatment, the handle broke off and the patient was trapped in the chamber. The technician called the clinical coordinator and the program manager immediately. Maintenance was called and the patient was removed from the chamber after 20 minutes of being in there. The manufacturer will also be called in to make sure that the machine is safe for patient use before we resume treatments. Manufacturer response for hyperbaric chamber, hyperbaric chamber (per site reporter): notified and evaluated chamber.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6036511 |
| MDR Report Key | 6036511 |
| Date Received | 2016-10-18 |
| Date of Report | 2016-09-15 |
| Date of Event | 2016-09-13 |
| Report Date | 2016-09-15 |
| Date Reported to FDA | 2016-09-15 |
| Date Reported to Mfgr | 2016-09-15 |
| Date Added to Maude | 2016-10-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARA-MED |
| Generic Name | CHAMBER, HYPERBARIC |
| Product Code | CBF |
| Date Received | 2016-10-18 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | N/A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENVIRONMENTAL TECTONICS CORP. |
| Manufacturer Address | 125 JAMES WAY SOUTHAMPTON PA 18966 US 18966 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-18 |