MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-03 for VITAERIS 320 manufactured by Oxyhealth Llc.
[71886827]
Over the past month, the inside zipper of our oxyhealth vitaeris 320 (sn (b)(4)) has come apart under the normal operating pressure of 4lbs pressure. Both the top and inside (lower) zipper were entirely zipped to the end of the zippers. The chamber was inflated to 4lbs (1. 3ata) pressure for about two minutes at full inflation before there was a loud noise and the inside zipper came apart, and all air suddenly exhausted from the chamber (rapid deflation). After exiting the chamber, i was able to slide the zipper to the other end of the track, and then it zipped up fine again to the head-top end of the chamber and the chamber seemed to work fine. The top zipper was still totally zipped and not undone after the inside zipper fell apart. It has done this three times in the last month. We have not used the chamber since the last incident for fear of injuring patients. Oxyhealth has sent a zipper repair kit as a solution to fix the issue on my own.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068900 |
| MDR Report Key | 6459804 |
| Date Received | 2017-04-03 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-03-28 |
| Date Added to Maude | 2017-04-05 |
| 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 |
| 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 | VITAERIS 320 |
| Generic Name | PORTABLE HYPERBARIC CHAMBER |
| Product Code | CBF |
| Date Received | 2017-04-03 |
| Model Number | VITAERIS 320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OXYHEALTH LLC |
| Manufacturer Address | SANTA FE SPRINGS CA 90670 US 90670 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-03 |