MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH INTELLIVUE MICROSTREAM EXTENSION; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number 867041

Device Problems Device Sensing Problem (2917); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2021

Event Type  malfunction  

Event Description

Patient admitted.Decision made to electively intubate patient to protect airway.Patient arrived with end-tidal co2 (etco2) cannula in place and connected to etco2 pod.Etco2 not consistently picking up.Patient intubated by nurse practitioner (np), unable to see etco2 on screen, waveform briefly appeared than disappeared, but + bilateral breath sounds, + mist in endotracheal tube (ett).New etco2 pod brought into room.Etco2 detected with new pod with initial etco2 32.

• Brand Name: INTELLIVUE MICROSTREAM EXTENSION
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH; 222 jacobs street; cambridge MA 02141
• MDR Report Key: 12473963
• MDR Text Key: 271492610
• Report Number: 12473963
• 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
• Type of Report: Initial
• Report Date: 08/31/2021

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: No Information
• Device Model Number: 867041
• Device Catalogue Number: 867041
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 540 DA