MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER

Model Number	862442
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported they did not hear an alarm sound for that value they were seeing for the spo2.Expected an alarm to sound for desaturation value before 70.It is unknown if the device was in use at time of event, and there was no adverse event reported.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
Philips reached out for more information regarding this case; however, the customer responded through the key market (km) that they were no longer interested in pursuing the investigation any further.The philips technical consultant (tc) had been onsite and tested the unit using the customer's own simulation equipment.Neither the customer nor the philips tc could replicate the issue, and the attached module passes functional checks and alarms as intended.The customer indicated they saw this issue as resolved.The customer indicated they saw this issue as resolved.The device remains at the customer site.
Event or Problem Description
Philips received a complaint on the intellivue multi measurement server indicating the customer expected an alarm to sound for desaturation value before 70.The nurse in charge of the baby did not hear an alarm sound for the spo2 value witnessed.The device was in use monitoring a patient at the time of the event, there was no patient harm.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER
• Common Device Name: INTELLIVUE MULTI MEASUREMENT SERVER
• 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: 18032408
• Report Number: 9610816-2023-00555
• Device Sequence Number: 17883083
• Product Code: MHX
• UDI-Device Identifier: 00884838000254
• UDI-Public: 00884838000254
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122439
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 862442
• Device Catalogue Number: 862442
• 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: 10/02/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown