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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT

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EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT Back to Search Results
Model Number HEM1
Device Problems Incorrect Measurement (1383); High Readings (2459)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2019
Event Type  malfunction  
Manufacturer Narrative
The product has not been received for evaluation. Once the product is returned and evaluated a supplemental report will be submitted with the evaluation findings. The device history record review has been completed and all manufacturing inspections passed with no non-conformances. The record of servicing was reviewed and there are no previous records. The udi is (b)(4).
 
Event Description
It was reported that a hemosphere instrument (hem1 monitor), swan ganz module and cable were in use during patient monitoring when the cardiac output and cardiac index readings were ¿abnormally high¿ for the patient¿s condition, per the clinician. The ci reading was 6. 7. The monitor, cable and sg module were exchanged for other equipment and the readings were down to normal. A swan ganz catheter was in use with the patient and was not exchanged and was eliminated as a contributor. There was no inappropriate patient treatment administered. There was no patient harm or injury. The patient demographic information is not available.
 
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Brand NameHEMOSPHERE INSTRUMENT
Type of DeviceHEMOSPHERE INSTRUMENT
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
samantha eveleigh
one edwards way
irvine, CA 92614
9492503939
MDR Report Key8922599
MDR Text Key196411205
Report Number2015691-2019-03120
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup,Followup
Report Date 07/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHEM1
Device Catalogue NumberHEM1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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