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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, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2021
Event Type  malfunction  
Event Description
The customer called philips to report that, on (b)(6) 2021, the mp70 monitor labeled 2067 did not alarm for a patient¿s desaturation event after the initial alarm. 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 NameINTELLIVUE MP70
Type of DeviceINTELLIVUE MP70
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 street
cambridge, MA 02141
MDR Report Key11572060
MDR Text Key242728067
Report Number9610816-2021-10043
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151681
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number862451
Device Catalogue Number862451
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/27/2021
Event Location No Information
Date Manufacturer Received02/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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