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

Model Number 866462

Device Problem Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

Reporting address line 1: (b)(6).Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).

Event 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 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 an 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
• Type of Device: 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 rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16117458
• MDR Text Key: 308635664
• Report Number: 9610816-2023-00009
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838055094
• UDI-Public: 00884838055094
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• 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
• Device Operator: Health Professional
• Device Model Number: 866462
• Device Catalogue Number: 866462
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1