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

Model Number	865322
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	12/29/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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
• Common Device Name: 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 ; 70314632031
• MDR Report Key: 16245405
• Report Number: 9610816-2023-00043
• Device Sequence Number: 6408801
• Product Code: DSI
• UDI-Device Identifier: 00884838021884
• UDI-Public: 00884838021884
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K150310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial 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
• Operator of Device: Health Professional
• Device Model Number: 865322
• Device Catalogue Number: 865322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female