MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MICROSTREAM CO2 EXTENSION

Model Number M3015A

Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

A customer emergency medical technician (emt) reported that the etco2 module did not work as expected, while patient was in cardiac arrest.The patient was in cardiac arrest and intubated in the field by ems prior to arrival to the hospital.When the customer staff attempted to use etco2 module, no measurement or waveform displayed, despite using proper filter tubing.The staff noticed an error message at the bottom of monitor that indicated calibration was required.When a clinical specialist attached the module to another mx700, an inop message "c02 equip malf" and "co2 occlusion" displayed.Even when the monitor was placed in demo mode, no measurement for etco2 displayed.The emt stated that the staff used a portable etco2 monitor located on their code cart.The patient was transferred upstairs to inpatient unit, where patient subsequently passed away.The emt did not state that the malfunction of this equipment contributed to the death of the patient.

Manufacturer Narrative

A philips clinical specialist put the monitor in demo mode using the etco2 module and was not able to see a waveform displayed for etco2.The device was then given to the customer biomed for further review.Per statement from the hospital staff who reported the occurrence to the philips clinical specialist, the hospital staff did not believe the device contributed to the death of the patient, as this patient was already in cardiac arrest prior to arrival to the hospital.Additional information was requested for this case, however, no further information was provided; therefore, the root cause of the issue was not able to be determined.We will consider that the customer resolved the issue, as there have been no subsequent calls logged for this device.The device remains at the customer site.No further investigation is warranted at this time.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: MICROSTREAM CO2 EXTENSION
• Type of Device: MICROSTREAM CO2 EXTENSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8403197
• MDR Text Key: 138208069
• Report Number: 9610816-2019-00068
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K993383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3015A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death