MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5

Model Number	865024
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported to philips that the philips oximetry probe did not alarm and had a normal value range while the patient was having a "crisis of life".The patient was being monitored by another device that correctly alarmed.There was patient involvement was reported, but there was no harm or an adverse event reported.
Additional Manufacturer Narrative
Complaint evaluation: it is unknown how this issue was resolved.Multiple good faith effort attempts were made to obtain additional information but have been unsuccessful to date.Customer resolution and conclusion: good faith efforts were made to obtain additional information on how this issue was resolved for the customer but have been unsuccessful to date.The resolution is unknown at this time.No further investigation or action is warranted at this time.
Additional Manufacturer Narrative
D1 and d4 correction to product informaiton.H3 and h6: additional information received determined that the issue was with the attached philips m1133a oximetry probe providing a normal value range while the patient was having a "crisis of life".The customer confirmed the issue was not with the mp5 functionality.Functional testing could not be performed m1133a oximetry probe as it was confirmed that the consumables have been disabled and cannot be evaluated.No further investigation is available at this time.

• Brand Name: INTELLIVUE MP5
• Common Device Name: INTELLIVUE MP5
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen MA 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen MA 71034 ; GM 71034
• Manufacturer Contact: hisham alzayat ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15148012
• Report Number: 9610816-2022-00403
• Device Sequence Number: 2690188
• Product Code: DSI
• UDI-Device Identifier: 30884838010209
• UDI-Public: 30884838010209
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 865024
• Device Catalogue Number: 865024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 11/06/2023
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 01/27/2023; 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown