MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHYSIOLOGIC MONITOR MODULE, EXHALED CARBON DIOXIDE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number M3015A

Device Problems Mechanical Problem (1384); Failure to Recalibrate (1517)

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

Event Date 10/06/2018

Event Type  malfunction  

Event Description

All 4 of our co2 monitors were not working - biomed came and was able to re-calibrate 1 of them and took 3 back.This was a dangerous situation having vital equipment not working and giving false numerical readings.

• Brand Name: PHYSIOLOGIC MONITOR MODULE, EXHALED CARBON DIOXIDE
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; building 4; andover MA 01810
• MDR Report Key: 8132629
• MDR Text Key: 129320052
• Report Number: 8132629
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3015A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1