FDA Adverse Event Malfunction Summary report: N

CBK

MDR report key: 3474805 · Received October 17, 2013

Report

Report Number
8010042-2013-00196
Event Type
Malfunction
Date Received
October 17, 2013
Manufacturer
MAQUET CRITICAL CARE AB
Product Code
CBK
PMA / PMN Number
K062793
Removal / Correction Number
NA
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

FURTHER INFO SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

Description of Event or Problem · 1

(B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
533518 CBK SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

Patients

Seq Age Sex Outcome Treatment
1