FDA Adverse Event
Malfunction
Summary report: N
PUMP IN STYLE ADVANCED BREASTPUMP BACKPACK
MDR report key: 1883123
·
Received October 18, 2010
Report
- Report Number
- 1419937-2010-00033
- Event Type
- Malfunction
- Date Received
- October 18, 2010
- Date of Event
- April 22, 2010
- Report Date
- April 22, 2010
- Manufacturer
- MEDELA, INC.
- Product Code
- HGX
- PMA / PMN Number
- K031614
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER AND THE ORIGINAL PUMP RETURNED FOR EVALUATION. RESULTS OF THE EVALUATION BY THE MANUFACTURER INDICATED THE PC BOARD DID NOT SMOKE. NO OTHER RESULTS WERE NOTED AND THE PART WAS SCRAPPED. THEREFORE, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE ROOT CAUSE OF THE REPORTED EVENT. AS PART OF COMPLAINT REMEDIATION ACTIVITIES, HISTORICAL COMPLAINT RECORDS ARE BEING REVIEWED FOR POSSIBLE ADVERSE EVENTS. MEDELA IS COMMITTED TO CREATING AN EFFECTIVE COMPLAINT HANDLING PROCESS TO ASSURE COMPLAINTS ARE PROCESSED IN A TIMELY MANNER AND EVALUATED FOR PART 803 REPORTING.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THEY TURNED ON THEIR PUMP THAT MORNING AND SMOKE CAME FROM THE LEFT SIDE OF THE BAG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP IN STYLE ADVANCED BREASTPUMP BACKPACK | PUMP, BREAST, POWERED | HGX | MEDELA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |