MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-09-25 for HEALTHTRONICS OSSATRON OSA 120 NA manufactured by Sanuwave, Inc..
[20911919]
During pre-test start-up, a head collision sensor was activated and could not be de-activated by the device operator. The activation of this sensor prevented the use of the device. The pt had already been sedated in preparation for the procedure.
Patient Sequence No: 1, Text Type: D, B5
[21221239]
The machine has been taken out of svc pending full eval upon a visit of a svc engineer to the site. Initial phone screen indicates a sensor failure. This report is submitted because the pt had already been sedated. The procedure for pain treatment of plantar fasciitis had not begun.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1062240-2007-00001 |
| MDR Report Key | 2176693 |
| Report Source | 07 |
| Date Received | 2007-09-25 |
| Date of Report | 2007-09-24 |
| Date of Event | 2007-08-29 |
| Date Mfgr Received | 2007-08-29 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2011-08-01 |
| 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 Contact | PETER STEGAGNO, VP |
| Manufacturer Street | 11680 GREAT OAKS WAY |
| Manufacturer City | ALPHARETTA GA 30022 |
| Manufacturer Country | US |
| Manufacturer Postal | 30022 |
| Manufacturer Phone | 8665816849 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEALTHTRONICS OSSATRON |
| Generic Name | HEALTHTRONICS OSSATRON |
| Product Code | NBN |
| Date Received | 2007-09-25 |
| Model Number | OSA 120 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SANUWAVE, INC. |
| Manufacturer Address | 11680 GREAT OAKS WAY ALPHARETTA GA 30022 US 30022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-25 |