FDA Adverse Event
Malfunction
Summary report: N
NEMSCHOFF PERINATAL BASSINET
MDR report key: 2379060
·
Received August 15, 2011
Report
- Report Number
- 3008746933-2011-00004
- Event Type
- Malfunction
- Date Received
- August 15, 2011
- Date of Event
- February 2, 2000
- Report Date
- February 2, 2009
- Manufacturer
- NEMSCHOFF
- Product Code
- NZG
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CAPA INVESTIGATION OF BASSINET DRAWER OPENING IS ONGOING. WE ARE SUBMITTING THIS MEDWATCH 3500A FORM AS ADVISED BY THE MDR POLICY BRANCH (TELEPHONE CALL 08/11/2011). ADDITIONALLY, THE CALLER DID NOT SPECIFY THE NUMBER OF BASSINETS ON WHICH DRAWERS OPENED. A TOTAL OF 33 UNITS WERE SHIPPED TO THIS USER FACILITY. PER ADVICE OF MDR POLICY BRANCH (08/11/2011), WE ARE SUBMITTING ONE MEDWATCH REPORT WITH RESPECT TO THIS EVENT.
Description of Event or Problem · 1
DRAWERS OPEN UNIT IS PUSHED DOWN THE HALL. THIS EVENT WAS ALSO REPORTED TO US AGAIN ON 11/30/2009. CALLER DID NOT REPORT THAT THE PRODUCT TIPPED OR ANY PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEMSCHOFF PERINATAL BASSINET | BASSINET, HOSPITAL | NZG | NEMSCHOFF | BSNT01W | 633447-301070002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |