MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-05-04 for 3200 HYPERBARIC CHAMBER manufactured by Sechrist Industries, Inc..
[15196006]
The chamber is compressing faster than specified. At a rate of 1 the chamber is pressurizing a 41 sec/psi. When the pressure rate is set to 3 the compression is at the high end of the specification of 50sec/psi. The technician, stated that he is keeping an eye on the pressure and taking the necessary steps/precautions for patient safety.
Patient Sequence No: 1, Text Type: D, B5
[15691607]
Technician is scheduled for site visit to evaluation and provide service. Reported complaint was found during regularly scheduled testing. No patient involvement when complaint was found. A follow-up submission report of findings will be provided once the evaluation of the device is conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2012-00017 |
| MDR Report Key | 2566545 |
| Report Source | 06 |
| Date Received | 2012-05-04 |
| Date of Report | 2013-05-03 |
| Date of Event | 2012-04-03 |
| Date Mfgr Received | 2012-04-02 |
| Device Manufacturer Date | 2009-04-17 |
| Date Added to Maude | 2012-09-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 4225 EAST LA PALMA AVE. |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer Phone | 7145798400 |
| Manufacturer G1 | SECHRIST INDUSTRIES, INC. |
| Manufacturer Street | 4225 EAST LA PALMA AVE. |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92807 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3200 HYPERBARIC CHAMBER |
| Generic Name | CHAMBER, HYPERBARIC |
| Product Code | CBF |
| Date Received | 2012-05-04 |
| Model Number | 3200 |
| Catalog Number | 3200 |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | ANAHEIM CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-04 |