MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP50

Model Number 862115

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported they cannot retrieve a graph from (b)(6) 2022.The device was reported to be in use on a patient, and adverse event was reported and patient went into cardiac arrest.

Manufacturer Narrative

A philips remote service engineer (rse) spoke to the customer.The customer was advised retrieval of the graphs were not possible, as the device storage options were set for the following: wave storage ¿ 72 hours.Alarm storage ¿ 50 alarms.Additionally, the rse was able to identify the action taken at the central station where the patient was discharged without the user backing up the data.The customer was informed of the device storage options and that the user discharged the patient without backing up the data, therefore the graph retrieval was not possible.

Event Description

It was reported they cannot retrieve a graph from (b)(6) 2022.The device was reported to be in use on a patient, and there was an adverse event reported (cardio respiratory arrest).

• Brand Name: INTELLIVUE MP50
• Type of Device: INTELLIVUE MP50
• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13506964
• MDR Text Key: 285413282
• Report Number: 9610816-2022-00078
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862115
• Device Catalogue Number: 862116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2012
• 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): Hospitalization