MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-09-15 for RFG-3CF SYSTEM, 117 V/60 HZ RFG3CF11760 manufactured by Covidien Lp (valleylab).
[917172]
The report stated that at the beginning of the pain mgmt procedure, the temp on the generator would not go past 35. The machine was turned off and back on the temp would not go past 40. The generator was unplugged and turned back on and a different probe and pad were used but the temp still would not get above 40. The procedure was stopped. After the procedure, staff found that the pt had red, rash-like marks where the pad had been.
Patient Sequence No: 1, Text Type: D, B5
[8241906]
The incident device has been received and is under evaluation. When the device evaluation is complete, a follow-up report will be submitted. The grounding pad was discarded and will not be returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2008-00397 |
| MDR Report Key | 1165685 |
| Report Source | 05,06 |
| Date Received | 2008-09-15 |
| Date of Report | 2008-08-18 |
| Date of Event | 2008-08-18 |
| Date Mfgr Received | 2008-08-18 |
| Device Manufacturer Date | 2003-07-01 |
| Date Added to Maude | 2009-04-09 |
| 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 | MEDICAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIM SCHWARZ-MGR |
| Manufacturer Street | 5920 LONGBOW DR. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306245 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RFG-3CF SYSTEM, 117 V/60 HZ |
| Generic Name | PAIN MANAGEMENT GENERATOR |
| Product Code | NBN |
| Date Received | 2008-09-15 |
| Returned To Mfg | 2008-08-28 |
| Catalog Number | RFG3CF11760 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP (VALLEYLAB) |
| Manufacturer Address | 5920 LONGBOW DR. BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-15 |