MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS M3150 INFO CNTR LOCAL DATABASE REL N.0

Model Number 865436

Device Problem Delayed Alarm (1011)

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

Event Date 11/08/2023

Event Type  malfunction  

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.E1: reporting address state: (b)(6).

Event Description

The customer reported that spo2 alarms: 70% did not ring, rang at 89% after going back up, ch245.The device was in use on a patient at the time of the event.There was no adverse event reported.A good faith effort (gfe) request was made for log files and the central station log files were provided.

Manufacturer Narrative

The remote service engineer (rse) confirmed that the spo2 alarms at 70% did not sound, sounded at 89% after ascending.The rse retrieved the logs from the control panel and could not get the spo2 configuration from the customer.The complaint was escalated for technical investigation.A philips product support engineer (pse) evaluated the alarm log, configuration file picture and technical logs.The pse verified several log entries showing desaturation alarming below 80% including an entry at 08:19:50.703 for an alarm when the desat reached 70.The logs displayed alarming as designed.Based on the information available and the testing conducted, the reported problem was not confirmed.The device remains in use at the customer site.

• Brand Name: M3150 INFO CNTR LOCAL DATABASE REL N.0
• Type of Device: M3150 INFO CNTR LOCAL DATABASE REL N.0
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18499600
• MDR Text Key: 333112052
• Report Number: 1218950-2024-00025
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081983
• 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: 865436
• Device Catalogue Number: 865436
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2012
• 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