FDA Adverse Event
Malfunction
Summary report: N
BP ADVANCED PERSONAL DOUBLE
MDR report key: 3813440
·
Received March 31, 2014
Report
- Report Number
- 1419937-2014-00323
- Event Type
- Malfunction
- Date Received
- March 31, 2014
- Date of Event
- March 19, 2014
- Report Date
- March 27, 2014
- Manufacturer
- MEDELA, INC.
- Product Code
- HGX
- PMA / PMN Number
- K031614
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A REPLACEMENT PUMP. INCLUDING TRANSFORMER, WAS SENT TO THE CUSTOMER. THE CAUSE OF THE BREACH IN THE REV N TRANSFORMER HAS NOT BEEN DETERMINED AT THIS TIME. IT IS CURRENTLY BEING INVESTIGATED UNDER (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE TRANSFORMER FOR HER ADVANCED PERSONAL DOUBLE BREAST PUMP WOULD NOT POWER ON HER DEVICE. UPON RECEIPT IN THE SERVICE CENTER, THE TRANSFORMER WAS FOUND TO BE BREACHED, WHICH IS A SAFETY RISK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189878 | BP ADVANCED PERSONAL DOUBLE | HGX | MEDELA, INC. | 57065/9207010 | REV N-LOT 1313 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |