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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: XPERIM HARDWARE
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XPERIM HARDWARE Back to Search Results
Model Number 453564667151
Medical Device Problem Code Application Program Problem (2880)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/05/2021
Type of Reportable Event Malfunction
Event or Problem Description
The customer reported that occasionally pressure readings do not change.The pressure waveform is correct.The device was not in use on a patient at the time of the event.
 
Event or Problem Description
The customer reported that occasionally pressure readings do not change.The pressure waveform is correct.The device was in use on a patient.There was no report of patient or user harm.
 
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Brand Name
XPERIM HARDWARE
Common Device Name
XPERIM HARDWARE
MDR Report Key12174722
Report Number1051786-2021-10034
Device Sequence Number19066369
Product Code MWI
UDI-Device Identifier00884838083820
UDI-Public00884838083820
Combination Product (Y/N)N
Initial Reporter CountryGR
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 Number453564667151
Device Catalogue Number453564667151
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date07/05/2021
Initial Date Received by Manufacturer 07/05/2021
Supplement Date Received by Manufacturer07/05/2021
Initial Report FDA Received Date07/15/2021
Supplement Report FDA Received Date10/22/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured10/05/2018
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
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