FDA Adverse Event Malfunction Summary report: N

6000CMS

MDR report key: 3190855 · Received June 14, 2013

Report

Report Number
1722139-2013-01906
Event Type
Malfunction
Date Received
June 14, 2013
Date of Event
October 7, 2010
Report Date
September 13, 2011
Manufacturer
MOOG DEVICE GROUP
Product Code
FRN
PMA / PMN Number
K981816
Removal / Correction Number
Z-1867-2011
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

NEW PUMP SOFTWARE WAS INSTALLED. REF RECALL NUMBER Z-1867-2011.

Description of Event or Problem · 1

INFO RECEIVED STATES THAT PUMP HAD EXPERIENCED ERROR CODE 36.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
272135 6000CMS FRN MOOG DEVICE GROUP 6000CMS

Patients

Seq Age Sex Outcome Treatment
1