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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE SWAN GANZ MODULE

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EDWARDS LIFESCIENCES HEMOSPHERE SWAN GANZ MODULE Back to Search Results
Model Number HEMSGM10
Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/22/2019
Event Type  malfunction  
Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not been received yet.Upon return of the product, a supplemental report will be submitted with the evaluation findings.The device history record review is pending.When the findings are available the information will be submitted in a supplemental report.
 
Event Description
It was reported that there was a fluctuation of cardiac index values during patient monitoring with a hemosphere swan ganz module.The values fluctuated from 1.3 to 2.8.The patient was stable with a normal rhythm and with good pulses.An appropriate pa waveform was displayed.The suspect swan ganz module was removed and replaced with another swan ganz module and then the values were appropriate with no other changes.There was no inappropriate patient treatment administered.There was no patient harm or injury.The patient demographic information has not been provided.
 
Manufacturer Narrative
One swan ganz module was received for product evaluation.The suspect sg module was connected to a known good working hemosphere instrument (monitor) for testing and analysis.The system verification test was performed and left to run for over an hour.The cardiac output readings obtained were within appropriate parameters.The functional test was performed and the module passed the test without any issues noted.An external inspection was performed and there was no visible physical damage identified.There was no defect found.The reported event was not confirmed by evaluation.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.It is unknown whether any user or procedural factors contributed 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
The suspect swan ganz module was not returned by the facility for product evaluation after several attempts have been made.Edwards is unable to confirm or negate the customers experience without the return of the suspect device.If the product is received, a supplemental report will be submitted.The device service history record review was completed and all manufacturing inspections passed with no non-conformance's.There was no previous related record of servicing.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.It is unknown whether any user or procedural factors contributed 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.The udi is (b)(4).
 
Manufacturer Narrative
Corrected data: f10, h6.Reference capa-20-00141.
 
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Brand Name
HEMOSPHERE SWAN GANZ MODULE
Type of Device
HEMOSPHERE SWAN GANZ MODULE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
MDR Report Key8425963
MDR Text Key139055637
Report Number2015691-2019-00898
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,Followup
Report Date 02/22/2019
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 Date11/28/2023
Device Model NumberHEMSGM10
Device Catalogue NumberHEMSGM10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2019
Initial Date Manufacturer Received 02/22/2019
Initial Date FDA Received03/15/2019
Supplement Dates Manufacturer Received04/01/2019
05/07/2019
07/23/2020
Supplement Dates FDA Received04/08/2019
05/08/2019
01/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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