MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS MEDICAL ANESTHESIA MONITOR, MULTI GAS; MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number M1019A

Device Problem Pumping Problem (3016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2020

Event Type  malfunction  

Event Description

Anesthesiologist reported the anesthesia machine had pump issues during a case.Fda safety report id# (b)(4).

• Brand Name: PHILIPS MEDICAL ANESTHESIA MONITOR, MULTI GAS
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 9902954
• MDR Text Key: 185930791
• Report Number: MW5093975
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1019A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 100 YR