FDA Adverse Event
Malfunction
Summary report: N
ASKU
MDR report key: 2132011
·
Received June 16, 2011
Report
- Report Number
- 2182208-2011-00947
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Removal / Correction Number
- Z-0430-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. 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 LOWER CASE WAS ALSO NOTED TO BE BROKEN AND THE KEYBOARD PAD SCRATCHED.
Description of Event or Problem · 1
IT WAS REPORTED THE UNIT WOULDN'T TURN ON, AND IT WAS POWERING DOWN ON ITS OWN. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. FOLLOW-UP INFORMATION RECEIVED DETERMINED THERE WAS NO PATIENT INVOLVEMENT. THE CONDITION WAS FOUND PRIOR TO USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASKU | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC, INC. | 5388 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |