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

Model Number 867036

Device Problem No Audible Alarm (1019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2024

Event Type  malfunction  

Event Description

The customer reported that during a test on simulator, when the customer generates a ventricular fibrillation, the monitor does not emit any alarm.The device was not in use on a patient at the time of event, there was no adverse event reported.

Manufacturer Narrative

E1: reporting institution phone #: (b)(6).E1: reporter phone #: (b)(6).Additional diagnostic/functional testing was not performed.The customer reports that during a simulator test, when the customer generates ventricular fibrillation, the monitor does not emit any alarms.Based on the information available the cause of the reported problem was a defective ecg measurement board.The reported problem was confirmed.Replacement parts were ordered and shipped to the customer site.We will consider that the customer resolved the issue using the replacement parts ordered from philips.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MMX
• Type of Device: INTELLIVUE MMX
• 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: hauke schik ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19183711
• MDR Text Key: 341532477
• Report Number: 9610816-2024-00230
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838086760
• UDI-Public: 00884838086760
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K181831
• 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

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: Health Professional
• Device Model Number: 867036
• Device Catalogue Number: 867036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2022
• 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