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

Model Number 865024

Device Problem Incorrect Measurement (1383)

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

Event Date 12/03/2021

Event Type  malfunction  

Event Description

It was reported blood oxygen (spo2) measurements were inaccurate.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

A philips authorized service provider (asp) went to the customer site.The asp confirmed the reported issue, but upon further troubleshooting of the device, was unable to identify the cause of the measurement inaccuracy.The customer was advised to continue using the device.No further investigation or action is warranted at this time.

• Brand Name: INTELLIVUE MP5
• Type of Device: INTELLIVUE MP5
• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13026742
• MDR Text Key: 282958950
• Report Number: 9610816-2021-10552
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000230
• UDI-Public: 00884838000230
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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: 865024
• Device Catalogue Number: 865024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• 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