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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70
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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70 Back to Search Results
Model Number 862451
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
Event Type  malfunction  
Event Description
The customer reported the non-invasive blood pressure (nibp) on their mp70 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 reported to be in use on a patient, but no adverse event to patient or user was reported.
 
Event Description
The customer reported the non-invasive blood pressure (nibp) on their mp70 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 reported to be in use on a patient, but no adverse event to patient or user was reported.
 
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Brand Name
INTELLIVUE MP70
Type of Device
INTELLIVUE MP70
Manufacturer (Section D)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM  71034
MDR Report Key12062100
MDR Text Key258722928
Report Number9610816-2021-10181
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
PMA/PMN Number
K151681
Number of Events Reported1
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 Number862451
Device Catalogue Number862451
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date06/17/2021
Initial Date Manufacturer Received 06/17/2021
Initial Date FDA Received06/24/2021
Supplement Dates Manufacturer Received06/17/2021
Supplement Dates FDA Received09/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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