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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE OXIMETRY CABLE

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EDWARDS LIFESCIENCES HEMOSPHERE OXIMETRY CABLE Back to Search Results
Model Number HEMOXSC100
Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2019
Event Type  malfunction  
Manufacturer Narrative
The device has been returned for evaluation.The evaluation findings are not yet available.When the evaluation is completed, a supplemental report will be submitted with the results.The device service history record review is pending.When the results are available, a supplemental report will be submitted with the results.(b)(4).
 
Event Description
It was reported that there were variations in the sv02 values with the hemosphere oximetry cable.This was during patient monitoring.The values were from 69% to 38% and 90% to 30% to 40%.The hemosphere monitor was ruled out as suspect as the issue was isolated to the cable only.There was no inappropriate patient treatment administered.There was no patient harm or injury.Demographic information not available at this time.
 
Manufacturer Narrative
One hemosphere oximetry cable was returned for product evaluation.The cable was tested per the system verification test and left to run for one hour.The sv02 values remained within appropriate parameters.There were no error messages observed.The functional testing was performed and it passed the test.A visual inspection was conducted and there was no external physical damage identified.There was no defect found.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported issue was not confirmed by evaluation.There is no evidence or indication that a manufacturing defect is responsible for the issues; therefore no corrective action was taken.With any hemodynamic monitoring, oximetry readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make treatment decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.In this case it is unknown if user or procedural factors played a part in this event.There was no patient compromise noted in this event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
 
Manufacturer Narrative
Reference capa-20-00141.
 
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Brand Name
HEMOSPHERE OXIMETRY CABLE
Type of Device
HEMOSPHERE OXIMETRY CABLE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
MDR Report Key8292506
MDR Text Key135194536
Report Number2015691-2019-00326
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,Followup
Report Date 01/11/2019
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
Device Operator Health Professional
Device Expiration Date11/08/2021
Device Model NumberHEMOXSC100
Device Catalogue NumberHEMOXSC100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2019
Initial Date Manufacturer Received 01/11/2019
Initial Date FDA Received01/31/2019
Supplement Dates Manufacturer Received02/11/2019
07/23/2020
Supplement Dates FDA Received02/21/2019
01/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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