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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER
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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER Back to Search Results
Model Number 862442
Medical Device Problem Code No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/15/2021
Type of Reportable Event Malfunction
Event or Problem Description
The customer reported their intellivue multi measurement server (mss) did not alarm during a desaturation event on (b)(6) 2021.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
Event or Problem Description
The customer reported their intellivue multi measurement server (mss) did not alarm during a desaturation event on (b)(6) 2021.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 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 Key11705850
Report Number9610816-2021-10084
Device Sequence Number4331035
Product Code MHX
UDI-Device Identifier00884838000254
UDI-Public00884838000254
Combination Product (Y/N)N
Initial Reporter CountryUK
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 Biomedical Engineer
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
Operator of Device Health Professional
Device Model Number862442
Device Catalogue Number862442
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date04/15/2021
Initial Date Received by Manufacturer 04/15/2021
Supplement Date Received by Manufacturer04/15/2021
Initial Report FDA Received Date04/22/2021
Supplement Report FDA Received Date06/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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