FDA Adverse Event
Malfunction
Summary report: N
SM304 M-SERIES W/ZOOM
MDR report key: 2946179
·
Received February 6, 2013
Report
- Report Number
- 0001831750-2013-00805
- Event Type
- Malfunction
- Date Received
- February 6, 2013
- Date of Event
- January 15, 2013
- Report Date
- January 15, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- INK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOOM HANDLES WERE BROKEN WITH SHARP EDGES.
Additional Manufacturer Narrative · 1
THIS IS A DUPLICATE OF MFR REPORT # 1831750-2012-12782. THE SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1025000000 REPORTED FOR THIS COMPLAINT WERE ACCIDENTALLY SUBMITTED INTO THE COMPLAINT HANDLING SYSTEM TWICE FOR THE EXACT SAME COMPLAINT INSTANCE. PLEASE REFER TO MFR REPORT # 1831750-2012-12782 FOR FULL REPORTING OF SERIAL NUMBER (B)(4) AND CATALOG NUMBER 6390000000 FOR THIS COMPLAINT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE ZOOM HANDLES WERE BROKEN. EXPOSED SHARP EDGES WERE REPORTED BY THE SERVICE TECHNICIAN.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE ZOOM HANDLES WERE BROKEN. EXPOSED SHARP EDGES WERE REPORTED BY THE SERVICE TECHNICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50955 | SM304 M-SERIES W/ZOOM | POWERED WHEELED STRETCHER | INK | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |