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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 SLCP
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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER SLCP Back to Search Results
Model Number 866462
Medical Device Problem Code Loss of Data (2903)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/15/2021
Type of Reportable Event Malfunction
Event or Problem Description
The customer reported a loss of spo2 parameter data with their intellivue multi measurement server slcp.It is unknown if the device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
 
Event or Problem Description
The customer reported a loss of spo2 parameter data with their intellivue multi measurement server slcp.It is unknown if the device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
 
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Brand Name
INTELLIVUE MULTI MEASUREMENT SERVER SLCP
Common Device Name
INTELLIVUE MULTI MEASUREMENT SERVER SLCP
Manufacturer (Section D)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM  71034
MDR Report Key11608905
Report Number9610816-2021-10064
Device Sequence Number4010081
Product Code MHX
UDI-Device Identifier00884838055094
UDI-Public00884838055094
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K150975
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
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 No Information
Device Model Number866462
Device Catalogue Number866462
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2021
Distributor Facility Aware Date03/15/2021
Initial Date Received by Manufacturer 03/15/2021
Supplement Date Received by Manufacturer03/15/2021
Initial Report FDA Received Date04/02/2021
Supplement Report FDA Received Date05/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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