FDA Adverse Event
Other
Summary report: N
BEDSIDE
MDR report key: 2699162
·
Received August 13, 2012
Report
- Report Number
- 1218087-2012-00037
- Event Type
- Other
- Date Received
- August 13, 2012
- Manufacturer
- PACE MEDICAL, INC.
- Product Code
- DTE
- PMA / PMN Number
- P920032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER RETURNED DEVICE WITH THE COMPLAINT THAT IT WAS NOT PACING. THE DEVICE WAS EXAMINED AND IT WAS FOUND THAT THE OUTPUT CONNECTOR WIRES NEEDED TO BE RE-SOLDERED. THIS TASK WAS PERFORMED AND NO OTHER FAULTS WERE FOUND. THE DEVICE WAS RE-CALIBRATED AND FINAL TESTED. ALL TESTS WERE PASSED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. REASON FOR COMPLAINT: UNKNOWN - MAY HAVE BEEN DAMAGED BY HOSPITAL EBME DEPARTMENT OR THE RESULT OF ROUGH HANDLING OR A SUDDEN IMPACT.
Description of Event or Problem · 1
PACE MEDICAL WAS NOTIFIED ON JUNE 27, 2011 BY (B)(6) VIA LETTER THAT UNIT HAD A FAULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BEDSIDE | TEMPORARY CARDIAC PACEMAKER | DTE | PACE MEDICAL, INC. | 4170 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |