ASKU
Report
- Report Number
- 2183613-2010-00139
- Event Type
- Malfunction
- Date Received
- August 17, 2010
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 COULD NOT DUPLICATE THE REPORTED EVENT. ANALYSIS DID FIND THAT THE UPPER AND LOWER CASES WERE BROKEN, THE SIDE BAIL COVERS WERE BROKEN, THE BATTERY RELEASE, HEART BLOCK, HEART WIRE CONTACTS, BATTERY DRAWER, RELEASE SPRING, BATTERY FLEX AND HEART LEAD FLEX WERE CONTAMINATED, THE LEAD FLEX COVER WAS CORRODED, THE RING COVER AND RING BAIL WERE MISSING, THE BATTERY CONTACTS WERE CONTAMINATED AND THE KEYBOARD AND ENCODER FLEX WERE OUT OF SPECIFICATION.
IT WAS REPORTED THAT THE RATE CONTROL IS INTERMITTENT. THE RATE GOES UP WHEN THE CONTROL IS TURNED DOWN OR GOES DOWN WHEN TURNED UP. FOLLOW-UP INFORMATION RECEIVED FOUND THE DEVICE WAS CONNECTED TO A PATIENT AT THE TIME OF THE EVENT, BUT THERE WAS NO PATIENT INJURY.
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 |