MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MICROSTREAM CO2 EXTENSION

Model Number M3015A

Device Problem Disconnection (1171)

Patient Problem Cardiac Arrest (1762)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer called philips on (b)(6) 2020 initially to report that their co2 module was disconnecting from the host mx800 beside monitor.Following the initial call, the customer provided the following information on 12nov2020: ¿on (b)(6) 2020 at approximately 3:15 pm, emergency department staff complained that the co2 module is intermittently disconnecting from host monitor during a code blue case.The clinical staff exchanged the co2 module, only to observe the same behavior.The patient coded blue due to a cardiac arrest.

Manufacturer Narrative

There is insufficient data available to philips for philips to determine the cause of the respective incident, however, sn (b)(6) has been reported not to have been in use during the patient event.Good faith efforts to obtain additional information was conducted, but the attempt was only partially successful.The customer has stated that the device did not cause or contribute to the patient¿s injury, they are unsure about the calibrated status of the co2 extensions prior to the patient event, and that they were unable to calibrate the co2 extensions following the patient event.The customer has stated that the co2 module extensions have remained out of clinical use on patients, and the customer has confirmed operational functionality of concomitant x2 and mx800 devices.Philips has ruled out the issues described in service bulletin sb86202966a and recommends that all msl pins, connectors, and/or cables of the co2 module extensions, as well as the concomitant x2 and m800, be checked for operational functionality as a possible solution to the issue described.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: 10860042
• MDR Text Key: 216891608
• Report Number: 9610816-2020-00424
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening