MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-05-26 for MONOPLACE HYPERBARIC CHAMBER 3200 manufactured by Sechrist Industries, Inc..
[19202996]
Medwatch received from fda via mail (b)(6) 2010. Two medwatch forms submitted for each of the chambers involved. Reference 2020676-2010-00009. The following is directly transcribed from medwatch form. Event description: the two chambers will not emergently decompress to surface using the emergency vent button when the oxygen valves are cut off to meet two minutes national fire protection association (nfpa) requirements. The chambers will decompress but not as quickly as they should. Both chambers returned for the required ten year retrofit in 2007 and 2008. Health professional's impression there is a potential for harm to the pt as the employee if there is a fire and the chamber does not decompress in a timely manner. The pt was undergoing hypobaric therapy for treatment of a wound. Device usage problem: device malfunction - that is, the device did not do what it was supposed to do.
Patient Sequence No: 1, Text Type: D, B5
[19516503]
Attempts to schedule on site eval of devices and obtain clarification of malfunction reported from with user facility unsuccessful. Will continue attempts to make contact and will submit updated information when received in f/u reports.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2010-00008 |
| MDR Report Key | 1708037 |
| Report Source | 00 |
| Date Received | 2010-05-26 |
| Date of Report | 2010-05-26 |
| Date of Event | 2010-04-08 |
| Date Facility Aware | 2010-05-25 |
| Date Mfgr Received | 2010-04-26 |
| Device Manufacturer Date | 1997-08-22 |
| Date Added to Maude | 2011-02-10 |
| 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 | 0 |
| 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 | MONOPLACE HYPERBARIC CHAMBER |
| Generic Name | 3200 |
| Product Code | CBF |
| Date Received | 2010-05-26 |
| Model Number | 3200 |
| Catalog Number | 3200 |
| Lot Number | NA |
| 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 | 1. Other | 2010-05-26 |