FDA Adverse Event
Malfunction
Summary report: N
ASKU
MDR report key: 1863257
·
Received October 9, 2010
Report
- Report Number
- 2183613-2010-00240
- 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 RELEASE, BATTERY DRAWER, AND BATTERY DRAWER O-RING WERE ALSO FOUND TO BE CONTAMINATED, THE LCD LENS ADHESIVE WAS MISALIGNED, THE KEYBOARD WAS SCRATCHED, AND THE LOWER CASE AND LCD DISPLAY WAS OUT OF SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE SHUT DOWN AT POWER UP AND SELF-TEST FAILED. THERE WAS NO PATIENT INCIDENT.
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 |