MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-23 for HYPERBARIC CHAMBER manufactured by .
[114947768]
My brother was in the hospital medical center in (b)(6), and his fingers were burned and because his health was. Based the hospital refused to treat him with the hypobaric chamber and told him he was not healthy enough to participate with the treatment of the hypobaric chamber. But because of my brother (b)(6)'s many requests and then they allowed him to take part in the treatment. And he died leaving the chamber, his lungs gave out and he went into cardiac arrest and died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078516 |
| MDR Report Key | 7713784 |
| Date Received | 2018-07-23 |
| Date of Report | 2018-07-22 |
| Date of Event | 2018-07-08 |
| Date Added to Maude | 2018-07-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 |
| Generic Name | HYPERBARIC CHAMBER |
| Product Code | CBF |
| Date Received | 2018-07-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-07-23 |