FDA Adverse Event
Malfunction
Summary report: N
ASKU
MDR report key: 1863288
·
Received October 9, 2010
Report
- Report Number
- 2183613-2010-00249
- Event Type
- Malfunction
- Date Received
- October 9, 2010
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE DEVICE WOULD NOT POWER UP. THE CAUSE WAS THE MAIN PCB (PRINTED CIRCUIT BOARD). THE BATTERY CONTACTS WERE ALSO FOUND TO BE COMPRESSED AND BATTERY DRAWER O-RING MISSING.
Description of Event or Problem · 1
IT WAS REPORTED THAT SELF-TEST FAILED, AND THE DEVICE SHUTDOWN. FOLLOW-UP INFORMATION RECEIVED DETERMINED THERE WAS NO PATIENT INVOLVEMENT. THE EVENT OCCURRED DURING REGULAR BIOMED TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASKU | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC MILACA INC. | 5388 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |