FDA Adverse Event
Malfunction
Summary report: N
BP ADV PERSONAL DOUBLE
MDR report key: 7356671
·
Received March 21, 2018
Report
- Report Number
- 1419937-2018-00085
- Event Type
- Malfunction
- Date Received
- March 21, 2018
- Date of Event
- March 9, 2018
- Report Date
- March 21, 2018
- Manufacturer
- MEDELA LLC
- Product Code
- HGX
- PMA / PMN Number
- K031614
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. FOLLOW UP WITH THE CUSTOMER TO GET ADDITIONAL INFORMATION IS ONGOING. THE ISSUE WITH A DAMAGED REV N POWER SUPPLY FOR THE PUMP IN STYLE DEVICE WAS ADDRESSED IN INVESTIGATION (B)(4), WHICH WAS TRENDED AS PART OF THE EFFECTIVENESS CHECK FOR (B)(4), WHICH FOUND THAT THE POWER SUPPLIES WERE BEING DAMAGED DURING SHIPMENT FROM THE MANUFACTURER TO MEDELA. AS A PART OF ROUTINE CONTINUOUS IMPROVEMENT ACTIVITIES, THE REV N POWER SUPPLY WAS REPLACED WITH A REV P POWER SUPPLY, MANUFACTURED UNDER A REVISED DESIGN AND BY A DIFFERENT MANUFACTURER.
Description of Event or Problem · 1
ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE HOUSING ON THE POWER SUPPLY FOR HER PUMP IN STYLE BREAST PUMP BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203161 | BP ADV PERSONAL DOUBLE | PUMP, BREAST, POWERED | HGX | MEDELA LLC | 57065 | 9207010/REV N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |