MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS MULTIGAS MONITOR ANESTHESIA MONITOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number M1019A

Device Problems Failure to Zero (1683); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2021

Event Type  malfunction  

Event Description

Fda safety report id# during surgery for a lap chole, the anesthesia monitor read "gm component malfunction" and could not zero the co2.The biomed report states the unit was found to be defective and it required components were repaired/replaced.Fda safety report id# (b)(4).

• Brand Name: PHILIPS MULTIGAS MONITOR ANESTHESIA MONITOR
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 11453372
• MDR Text Key: 239216395
• Report Number: MW5099886
• Device Sequence Number: 1
• Product Code: CCK
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1019A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 46 YR