MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP90

Model Number 862452

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported the non-invasive blood pressure (nibp) on their mp90 intellivue patient monitor will display a -??- mark and the last know nipb measurement will be displayed and look like an active reading.The customer is concerned the patient will be treated based on an incorrect nibp reading.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

H3 other text : the customer resolved the issue.

Event Description

The customer reported the non-invasive blood pressure (nibp) on their mp90 intellivue patient monitor will display a -??- mark and the last know nipb measurement will be displayed and look like an active reading.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: INTELLIVUE MP90
• Type of Device: INTELLIVUE MP90
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• MDR Report Key: 12061522
• MDR Text Key: 258166847
• Report Number: 9610816-2021-10183
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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: 862452
• Device Catalogue Number: 862452
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/17/2021
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1