MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX500 PATIENT MONITOR

Model Number 866064

Device Problem No Audible Alarm (1019)

Patient Problems Bradycardia (1751); Malaise (2359)

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

It was reported on (b)(6) 2023, the patient desaturated and developed bradycardia, for which the monitor did not generate an alarm; however, it was indicated an alarm was generated at the central station.It was indicated the bradycardia was not managed in time and required nursing intervention.

Manufacturer Narrative

A good faith effort (gfe) was performed to clarify the type of patient intervention that was performed.However, no additional details were provided.The complaint could not be escalated for technical investigation, as there was insufficient information to investigate.Gfe attempts have been made to obtain the logs and bed label for the event, but no additional information was provided.The cause of the reported problem is unknown.The reported problem was not confirmed.Due to the lack of available information, the exact cause for the reported issue remains unknown, and a malfunction of the device cannot be ruled out.

• Brand Name: INTELLIVUE MX500 PATIENT MONITOR
• Type of Device: INTELLIVUE MX500 PATIENT MONITOR
• 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 ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 18256888
• MDR Text Key: 329611105
• Report Number: 9610816-2023-00637
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038776
• UDI-Public: 00884838038776
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131872
• 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: 866064
• Device Catalogue Number: 866064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• 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