MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-08-13 for MICRO-PACE 4570 manufactured by Pace Medical, Inc.
[2862475]
Pace medical was notified on 09/01/2011 by (b)(6) via letter that unit has a fault.
Patient Sequence No: 1, Text Type: D, B5
[10127196]
Customer returned device stating that the sensitivity settings were out of spec. The device was examined and the complaint was confirmed. The device was re-calibrated and final tested. All tested were passed and the device was returned to the customer. Reason for complaint: device had not been returned to mfr for approx four years for any annual servicing. Component drift may have caused settings to be needed to be recalibrated or ebme staff tried to calibrate themselves.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218087-2012-00048 |
| MDR Report Key | 2699210 |
| Report Source | 01,07 |
| Date Received | 2012-08-13 |
| Date Mfgr Received | 2011-09-07 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2012-08-24 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 310 SOUTH ST, STE 2 |
| Manufacturer City | PLAINVILLE MA 02762 |
| Manufacturer Country | US |
| Manufacturer Postal | 02762 |
| Manufacturer Phone | 5083163861 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRO-PACE |
| Generic Name | TEMPORARY CARDIAC PACEMAKER |
| Product Code | JOQ |
| Date Received | 2012-08-13 |
| Returned To Mfg | 2011-09-01 |
| Model Number | 4570 |
| Catalog Number | 4570 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PACE MEDICAL, INC |
| Manufacturer Address | PLAINVILLE MA 02762 US 02762 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-13 |