FDA Adverse Event
Malfunction
Summary report: N
ZOOM
MDR report key: 3213589
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-07769
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- April 25, 2013
- Report Date
- April 25, 2013
- Manufacturer
- EXTERNAL MANUFACTURER
- Product Code
- KRG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS REVEALED A DEFECTIVE INVERTER WHICH WAS CAUSING THE PROGRAMMER TO DISPLAY A BLANK SCREEN UPON BOOT UP. THE INVERTER COVER WAS ALSO FOUND TO BE MELTED FROM THE DEFECTIVE INVERTER. BOTH THE INVERTER AND INVERTER COVER WERE REPLACED. NO FURTHER PROBLEMS WERE DISCOVERED WITH THE PROGRAMMER.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY IDENTIFIED A PRODUCT PERFORMANCE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313917 | ZOOM | KRG | EXTERNAL MANUFACTURER | 3120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |