MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70

Model Number 862451

Device Problem Failure to Transmit Record (1521)

Patient Problem Cardiac Arrest (1762)

Event Date 06/29/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported during a code blue event, the nurse was unable to pull up end tidal monitoring on the cardiac monitor using the associated etco2 module.The device was in use at the time of event and there was adverse event.

Event Description

It was reported during a code blue event, the nurse was unable to pull up end tidal monitoring on the cardiac monitor using the associated etco2 module.The module was switched out 4 times and each module device failed to register etc02 on the screen.All other vital sign parameters were present on the screen.The device was in use at the time of event and there was adverse event.The means of evaluation is unknown, as well as how this issue was resolved.A good faith effort (gfe) was done requesting additional information.No further information regarding the reported issue were available.

• Brand Name: INTELLIVUE MP70
• Type of Device: INTELLIVUE MP70
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15379234
• MDR Text Key: 299463978
• Report Number: 9610816-2022-00480
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862451
• Device Catalogue Number: 862451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention