MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5SC SPOTCHECK MONITOR

Model Number 865322

Device Problem No Audible Alarm (1019)

Patient Problem Hypoxia (1918)

Event Date 12/29/2022

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

The customer reported that there was no alarm generated by the intellivue mp5sc spotcheck monitor when the patient's spo2 vitals in room 31t dropped below the desaturation alarm limit.The device was in use monitoring a patient at the time of the reported event.Staff intervention had to be performed to assist the patient.

Event Description

Philips received a complaint on the intellivue mp5sc spotcheck monitor indicating while it was paired to an intellivue mx40 device, the patient spo2 measurements dropped below the alarm desaturation limit, but the device did not produce an audible alarm.The spo2 level dropped to around 20% and the patient was treated by being placed on 100% oxygen.The patient made a full recovery.The following functional tests were performed: a philips field service engineer (fse) went to the customer site.The fse obtained the event logs.Review of the event logs concluded the intellivue mp5sc spotcheck monitor alarm volume was set to zero at the time of the event which is why no audible alarm was produced.The results of functional testing indicate that the device functioned according to specification.Based on the information available and the testing conducted, the cause of the reported problem was use error due to the customer setting the alarm volume to zero.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required.The device remains at the customer site.

• Brand Name: INTELLIVUE MP5SC SPOTCHECK MONITOR
• Type of Device: INTELLIVUE MP5SC SPOTCHECK 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: 16245405
• MDR Text Key: 308144314
• Report Number: 9610816-2023-00043
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838021884
• UDI-Public: 00884838021884
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 865322
• Device Catalogue Number: 865322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• 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
• Patient Sex: Female