MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH MAINSTREAM CO2 SENSOR; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Patient Problem Anxiety (2328)

Event Date 09/07/2023

Event Type  malfunction  

Event Description

Tested end tidal prior to conscious sedation had a waveform took cannula off as pt agitated with it on replaced at start of procedure was not able to obtain waveform attempted to reposition and reset unsuccessful.After sedation was told it had happened during previous sedation in same room.

• Brand Name: MAINSTREAM CO2 SENSOR
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH; 222 jacobs street; cambridge MA 02140
• MDR Report Key: 18011474
• MDR Text Key: 326616503
• Report Number: 18011474
• Device Sequence Number: 1
• Product Code: MHX
• 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: 09/29/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2190 DA
• Patient Sex: Female