Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER Back to Search Results
Model Number 862442
Medical Device Problem Code Unable to Obtain Readings (1516)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/24/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This emdr report was created due to product and registration changed.This is a complete supplemental report associated with 1218950-2021-10082.
 
Event or Problem Description
The customer reported there was a discrepancy between trace carried out with philips monitoring 12-lead ecg and the electrocardiograph.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTELLIVUE MULTI MEASUREMENT SERVER
Common Device Name
INTELLIVUE MULTI MEASUREMENT SERVER
Manufacturer (Section D)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM  71034
MDR Report Key12066142
Report Number9610816-2021-10185
Device Sequence Number4765107
Product Code MHX
UDI-Device Identifier00884838000254
UDI-Public00884838000254
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K122439
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
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
Operator of Device Health Professional
Device Model Number862442
Device Catalogue Number862442
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date02/24/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/25/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-