MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-14 for HYPERBARIC CHAMBER 31" manufactured by Summit To Sea.
[102583046]
I was sitting inside a hyperbaric chamber from summit to see and the zipper malfunctioned and the chamber popped open with me in it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075868 |
| MDR Report Key | 7340835 |
| Date Received | 2018-03-14 |
| Date of Report | 2018-03-13 |
| Date of Event | 2018-02-13 |
| Date Added to Maude | 2018-03-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | HYPERBARIC CHAMBER 31" |
| Generic Name | CHAMBER HYPERBARIC |
| Product Code | CBF |
| Date Received | 2018-03-14 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUMMIT TO SEA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-14 |