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 MINIATURE EV4543 manufactured by Pace Medical, Inc..
[2867975]
Pace medical was notified on march 29, 2011 by (b)(4) via letter that unit had a fault.
Patient Sequence No: 1, Text Type: D, B5
[10227168]
Device returned by customer stating the output controls were off of range. Device was investigated and fault was duplicated. The control knobs had become loose. The knobs were refitted properly and the device was recalibrated and final tested. The pacemaker passed all tests and was returned to the customer. Observation may have been caused by rough handling by hospital staff.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218087-2012-00012 |
| MDR Report Key | 2699014 |
| Report Source | 01,07 |
| Date Received | 2012-08-13 |
| Date Mfgr Received | 2011-05-05 |
| Device Manufacturer Date | 2005-05-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 310 SOUTH STREET SUITE 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 | MINIATURE |
| Generic Name | TEMPORARY CARIDAC PACEMAKER |
| Product Code | JOQ |
| Date Received | 2012-08-13 |
| Returned To Mfg | 2011-03-29 |
| Model Number | EV4543 |
| Catalog Number | EV4543 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |