MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-01-29 for MONOPLACE HYPERBARIC OXYGEN 21762 manufactured by Sechrist Industries, Inc..
[37607344]
Reported event is still pending evaluation.
Patient Sequence No: 1, Text Type: N, H10
[37607685]
It was reported that during (hbot) a routine hyperbaric oxygen therapy patient turned on her side while in the chamber and the backrest collapsed to flat position. Patient stated that she was not hurt and chose to continue therapy. Reportedly at the end of the therapy patient stated sharp mid back and shoulder pain. Patient was treated in the department and subsequently transferred to er for review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020676-2016-00002 |
| MDR Report Key | 5409797 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-01-29 |
| Date of Report | 2015-12-30 |
| Date of Event | 2015-12-23 |
| Date Added to Maude | 2016-02-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VICTGOR ARELLANO |
| Manufacturer Street | 4225 EAST LA PALMA AVE. |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer Phone | 7145798400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MONOPLACE HYPERBARIC OXYGEN |
| Generic Name | HYPERBARIC CHAMBER |
| Product Code | CBF |
| Date Received | 2016-01-29 |
| Model Number | 21762 |
| Catalog Number | 21762 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | ANAHEIM CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-29 |