MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-29 for SUNQUEST POWERPATH manufactured by Sunquest Info Systems.
[4893192]
This issue was found by a client at site. In powerpath, on rare instances, two reports may be created for the same case at the time of case sign-out. These reports may contain incomplete diagnostic info and may be sent over the results interface or distribution services.
Patient Sequence No: 1, Text Type: D, B5
[12295691]
Ninety five sites have been notified via product safety notice (psn) and a correction will be available as an emergency patch for all affected versions. There are 0 sites that have already been corrected. No instances of pt harm have been reported as a result of this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029302-2014-00004 |
| MDR Report Key | 4070910 |
| Report Source | 06 |
| Date Received | 2014-08-29 |
| Date of Report | 2014-08-22 |
| Date of Event | 2014-07-23 |
| Date Mfgr Received | 2014-07-23 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2014-09-15 |
| 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 | PATRICE NEDELEC, VP CLIENT EXPERI |
| Manufacturer Street | 250 S. WILLIAMS BLVD |
| Manufacturer City | TUCSON AZ 85711 |
| Manufacturer Country | US |
| Manufacturer Postal | 85711 |
| Manufacturer Phone | 5205702317 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNQUEST POWERPATH |
| Generic Name | POWERPATH |
| Product Code | NVV |
| Date Received | 2014-08-29 |
| ID Number | 9.5, 10.0, 10.1 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNQUEST INFO SYSTEMS |
| Manufacturer Address | 250 S. WILLIAMS BLVD TUCSON AZ 85711 US 85711 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-29 |