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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE CLEARSIGHT MODULE
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EDWARDS LIFESCIENCES HEMOSPHERE CLEARSIGHT MODULE Back to Search Results
Model Number HEMCSM10
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/07/2021
Event Type  malfunction  
Manufacturer Narrative
The product will not be returned as the serial number was not secured for the product that was used.The diagnostic log files will be returned and reviewed.The findings from the log files will be submitted in a supplemental report when available.The device history record review could not be completed as the serial number is unknown.The udi number is unknown as the serial number is unknown.
 
Event Description
It was reported that there were inaccurate values with the clearsight module during patient use.The ci was 1.4 for a laparoscopic prostatectomy.There was no inappropriate patient treatment administered.The patient demographics are not available, per the physician.There was no patient harm or injury.
 
Manufacturer Narrative
The diagnostic logs were requested but not received.There was an attempt to extract the logs for review, but data was not available.There are no findings available to submit.
 
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Brand Name
HEMOSPHERE CLEARSIGHT MODULE
Type of Device
CLEARSIGHT MODULE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
MDR Report Key12368189
MDR Text Key268225275
Report Number2015691-2021-04857
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
PMA/PMN Number
K203687
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHEMCSM10
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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