ASKU
Report
- Report Number
- 2183613-2011-00304
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S70
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
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 CUSTOMER COMMENT, THE MAIN PRINTED CIRCUIT (PC) BOARD AND INTERCONNECT FLEX WAS OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE RING COVER WAS BROKEN AND TWO SIDE BAIL COVERS WERE CONTAMINATED. A DETAILED ANALYSIS OF THE MAIN PC BOARD WAS PERFORMED. THE CAUSE OF THE FAILURE WAS CRACKED SOLDER JOINTS ON THE PC BOARD.
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 CUSTOMER COMMENT, THE MAIN PRINTED CIRCUIT (PC) BOARD AND INTERCONNECT FLEX WAS OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE RING COVER WAS BROKEN AND TWO SIDE BAIL COVERS WERE CONTAMINATED.
IT WAS REPORTED THE DEVICE WILL NOT STAY ON. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASKU | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC MILACA INC. | 5348 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |