FDA Adverse Event
Malfunction
Summary report: N
LD304 MATERNITY BED
MDR report key: 3241130
·
Received July 22, 2013
Report
- Report Number
- 0001831750-2013-06548
- Event Type
- Malfunction
- Date Received
- July 22, 2013
- Date of Event
- June 27, 2013
- Report Date
- June 27, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- HDD
- PMA / PMN Number
- K950889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS.
Additional Manufacturer Narrative · 1
MANUFACTURER¿S INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FOOTREST WAS NOT LOCKING IN PLACE PROPERLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FOOTREST WAS NOT LOCKING IN PLACE PROPERLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340465 | LD304 MATERNITY BED | TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) | HDD | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |