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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 Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/04/2020
Event Type  malfunction  
Manufacturer Narrative
It was reported that there were inaccurate pac measurements that were observed by the clinicians during patient monitoring.The hemosphere instrument (hem1) and the swan ganz module (sgm) were being used.The issue was not isolated to either unit.The edwards clinical field representative visited the facility to investigate.The clinicians were unable to identify which unit had the alleged failure, but they did know that the numbers displayed were inaccurate.The patient parameter numbers displayed and the numbers that were expected are unknown.The serial numbers of the units involved is unknown.The patient demographics are unknown.There will be no product return.There was no inappropriate patient treatment administered.There was no patient harm or injury.The sg module involved will be reported as an mdr submission, 2015691-2020-12202.
 
Event Description
It was reported that there were inaccurate pac measurements that were observed by the clinicians during patient monitoring.The hemosphere instrument (hem1) and the swan ganz module (sgm) were being used.The issue was not isolated to either unit.The edwards clinical field representative visited the facility to investigate.The clinicians were unable to identify which unit had the alleged failure, but they did know that the numbers displayed were inaccurate.The patient parameter numbers displayed and the numbers that were expected are unknown.The serial numbers of the units involved is unknown.The patient demographics are unknown.There will be no product return.There was no inappropriate patient treatment administered.There was no patient harm or injury.The sg module involved will be reported as an mdr submission.
 
Manufacturer Narrative
Corrected data: f10, h6.Reference capa-20-00141.
 
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Brand Name
HEMOSPHERE INSTRUMENT
Type of Device
HEMOSPHERE INSTRUMENT
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
MDR Report Key10171149
MDR Text Key196755394
Report Number2015691-2020-12204
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
PMA/PMN Number
K163381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHEM1
Device Catalogue NumberHEM1
Was Device Available for Evaluation? No
Date Manufacturer Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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