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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPERIM HARDWARE
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INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPERIM HARDWARE Back to Search Results
Model Number 453564241901
Medical Device Problem Code No Audible Alarm (1019)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/12/2021
Type of Reportable Event Malfunction
Event or Problem Description
The customer reported spo2 specifications in the examination room without sound.No vital signs sound for spo2 makes it difficult to continue working.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 spo2 specifications in the examination room without sound.No vital signs sound for spo2 makes it difficult to continue working.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
XPERIM HARDWARE
Common Device Name
XPERIM HARDWARE
Manufacturer (Section D)
INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS
12151 research parkway
orlando FL 32826
MDR Report Key11866515
Report Number1051786-2021-10021
Device Sequence Number17246890
Product Code MWI
UDI-Device Identifier00884838103610
UDI-Public00884838103610
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K101571
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other
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 Number453564241901
Device Catalogue Number453564241901
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date05/12/2021
Initial Date Received by Manufacturer 05/12/2021
Supplement Date Received by Manufacturer05/12/2021
Initial Report FDA Received Date05/21/2021
Supplement Report FDA Received Date06/08/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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