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

Model Number	866462
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer reported a neonatal disposable blood oxygen probe measurement error after one hour of measurement; the probe can't measure oximetry (spo2) after one hour.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.On 22dec2022, the philips distributor investigating the case found the spo2 was lost in isolation, and there were no error messages or alarms from other parameters that alerted the clinical staff to the problem.The distributor confirmed the spo2 sensor was faulty and replaced the spo2 sensor.The issue was resolved.The distributor advised the customer to order a replacement sensor.
Event or Problem Description
The customer reported a neonatal disposable blood oxygen probe measurement error after one hour of measurement; the probe can't measure oximetry (spo2) after one hour.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.On 22dec2022, the philips distributor investigating the case found the spo2 was lost in isolation, and there were no error messages or alarms from other parameters that alerted the clinical staff to the problem.The distributor confirmed the spo2 sensor was faulty and replaced the spo2 sensor.The issue was resolved.The distributor advised the customer to order a replacement sensor.Additional information was received on 10feb2023 indicating that there was a inoperative error message which had alerted the user to this issue.This is no longer consider a reportable event.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER SLCP
• Common Device Name: INTELLIVUE MULTI MEASUREMENT SERVER SLCP
• 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 ; 3000 minuteman road; andover, MA 01810 ; 9786593000
• MDR Report Key: 16120145
• Report Number: 9610816-2023-00005
• Device Sequence Number: 8426847
• Product Code: MHX
• UDI-Device Identifier: 00884838055094
• UDI-Public: 00884838055094
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150975
• 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,Distributor
• Initial Reporter Occupation: Physician
• 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: 866462
• Device Catalogue Number: 866462
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2021
• 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