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	01/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke with the customer biomedical engineer (biomed).The values measured/transmitted by the x1 device do not lead to red alarms on the monitor, only yellow ones.Cross-exchange and comparison with other parameter servers results in a problem with the named x1; a configuration problem on the monitor could be ruled out.As a solution, replacing the parameter board was recommended; the customer can carry out the replacement themselves; the system is out of use until the spare parts are installed.The customer was also informed about the possibility of repair at the philips repair workshop.Follow-up with the customer may be needed.A follow-up report will be submitted upon completion of the investigation.(b)(6).
Event or Problem Description
The module displays yellow alarms instead of red alarms.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
Based on the information available and the testing conducted, the cause of the reported problem was defective parameter board.The reported problem was confirmed.The engineer provided their analysis findings however we are unable to confirm the final disposition of the device because the customer refused service.The investigation concludes that no further action is required at this time.

• 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: 18613034
• Report Number: 9610816-2024-00048
• Device Sequence Number: 7508834
• Product Code: MHX
• UDI-Device Identifier: 00884838000254
• UDI-Public: 00884838000254
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility,Company Representative
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2012
• 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