FDA Adverse Event
Malfunction
Summary report: N
STANDARD VIDEO CART KIT
MDR report key: 6062511
·
Received October 27, 2016
Report
- Report Number
- 0002936485-2016-01015
- Event Type
- Malfunction
- Date Received
- October 27, 2016
- Date of Event
- September 30, 2016
- Report Date
- April 11, 2017
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- BZN
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. (B)(4).
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. ALLEGED FAILURE: CAUGHT ON FIRE. PROBABLE ROOT CAUSE: TOO MUCH HEAT, TRANSFORMER DESIGN, CART DESIGN, MANUFACTURING NONCONFORMITY, USE ERROR. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A VIDEO CART WAS PLUGGED INTO A NON STRYKER BOOM. AT PLUG IN, THE BOOM CAUGHT FIRE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A VIDEO CART WAS PLUGGED INTO A NON STRYKER BOOM. AT PLUG IN, THE BOOM CAUGHT FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712900 | STANDARD VIDEO CART KIT | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) | BZN | STRYKER ENDOSCOPY-SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |