MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP30

Model Number 862135

Device Problem Alarm Not Visible (1022)

Patient Problem Apnea (1720)

Event Date 01/06/2023

Event Type  malfunction  

Event Description

The customer reported that an apnea alarm was not forwarded.According to the user, the patient had to be resuscitated and the device did not display an alarm and transferred to the other rooms/monitors.During a test later, the error could not be reproduced and the alarm (targeted apnea) was also forwarded to the other monitors.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Manufacturer Narrative

A technical investigation could not be performed as the customer did not provide the correct requested logs to be reviewed.Several attempts were made to obtain the correct logs, but were not provided.Based on the information available the reported problem was not confirmed.Several attempts were made to obtain the correct log files for review, additional information regarding this case and patient condition, but the customer was unable to provided the requested information.In addition, the specialist nurse for anesthesia and intensive care medical device safety officer, medical device coordinator at the customer site, stated that they would close the case internally without identifying an exact cause.The customer considers the event not to be reportable as it was found that the alarm transmission from the affected bet to other bed was working as expected.

Event Description

Philips received a complaint on the intellivue mp30 indicating that the device did not display an apnea alarm and was not forwarded to the other rooms/monitors.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: INTELLIVUE MP30
• Type of Device: INTELLIVUE MP30
• 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, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 16210639
• MDR Text Key: 307891210
• Report Number: 9610816-2023-00034
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122439
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862135
• Device Catalogue Number: 862135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2013
• 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