MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-06-01 for CHAMBER, HYPERBARIC 3600E manufactured by Sechrist Industries, Inc..
[2743053]
Customer reports ground resistance of chamber during clinical use was above the specification. Customer measured the ground resistance after the treatment and found the ground resistance within specification.
Patient Sequence No: 1, Text Type: D, B5
[9828800]
On site investigation found the increased grounding was due to chamber power supply. Power supply is in route to chamber manufacturer for investigation. Customer reports the chamber is properly grounded per the manufacturer's grounding point described in the operator's manual. The manufacturer requires the chamber be properly grounded from the chamber ground connection to the hospital wall stud. With this ground installed customer reports the ground resistance is within specification. Follow-up submission will be provided on the results of the power supply investigation once they are available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2012-00030 |
| MDR Report Key | 2600711 |
| Report Source | 06 |
| Date Received | 2012-06-01 |
| Date of Report | 2012-06-01 |
| Date of Event | 2012-05-04 |
| Device Manufacturer Date | 2011-11-29 |
| Date Added to Maude | 2012-10-03 |
| 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 E. 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 W. 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 | CHAMBER, HYPERBARIC |
| Generic Name | HYPERBARIC MONOPLACE CHAMBER |
| Product Code | CBF |
| Date Received | 2012-06-01 |
| Model Number | 3600E |
| Catalog Number | 3600E |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | ANAHEIM CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-01 |