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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE; INTELLIVUE MICROSTREAM EXTENSION
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PHILIPS MEDICAL SYSTEMS INTELLIVUE; INTELLIVUE MICROSTREAM EXTENSION Back to Search Results
Model Number 867041
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event or Problem Description
The customer reported their intellivue microstream extension was involved in an incident and now the device is not showing spo2.No patient involvement.
 
Additional Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
INTELLIVUE
Common Device Name
INTELLIVUE MICROSTREAM EXTENSION
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
MDR Report Key10791814
Report Number9610816-2020-00403
Device Sequence Number16289676
Product Code MHX
UDI-Device Identifier00884838083585
UDI-Public(01)00884838083585
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K172904
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
Report Date (Section B) 10/28/2020
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 Number867041
Device Catalogue Number867041
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/28/2020
Supplement Date Received by Manufacturer10/28/2020
Initial Report FDA Received Date11/05/2020
Supplement Report FDA Received Date01/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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