FDA Adverse Event Malfunction Summary report: N

PHILIPS MEDIZIN SYSTEMS MONITORING DEVICE - ARTERIAL LINE

MDR report key: 8231463 · Received January 8, 2019

Report

Report Number
MW5082976
Event Type
Malfunction
Date Received
January 8, 2019
Date of Event
December 19, 2018
Report Date
January 3, 2019
Manufacturer
PHILIPS - BOBLINGEN GMBH
Product Code
MHX
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

PHILIPS MEDIZIN SYSTEMS MODULE - ARTERIAL LINE MODULE WOULD NOT WORK. THIS MODULE IS A PIECE OF THE MONITOR. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
17872 PHILIPS MEDIZIN SYSTEMS MONITORING DEVICE - ARTERIAL LINE MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS - BOBLINGEN GMBH M1006B

Patients

Seq Age Sex Outcome Treatment
1 65 YR