MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PHILIPS INTELLIVUE MICROSTREAM CO2 EXTENSION; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 862393

Device Problems Display or Visual Feedback Problem (1184); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2021

Event Type  malfunction  

Event Description

Etco2 (end-tidal carbon dioxide) module reading co2 of 150 with static waveform.After troubleshooting, the monitor read "etco2 occluded".After replacing the inline etco2, the same message persisted.Respiratory therapist changed the module and the readings returned to baseline.Proving the module to be defective.There was no harm in this event.This is not a recurring issue at our facility.

• Brand Name: PHILIPS INTELLIVUE MICROSTREAM CO2 EXTENSION
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; 3000 minuteman road; mail stop 4202; andover MA 01810
• MDR Report Key: 12819371
• MDR Text Key: 280815670
• Report Number: 12819371
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 862393
• Device Catalogue Number: 862393
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2021
• Date Report to Manufacturer: 11/16/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 730 DA
• Patient Sex: Male