MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE SWAN GANZ MODULE

Model Number HEMCSM10

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

The product will not be returned as the serial number was not secured at the time of the event.The device involved is not able to be identified.The device service history record review cannot be completed as the serial number is unknown.The udi number cannot be identified as the serial number is unknown.The log files are attempting to be obtained for review.When the findings are available the results will be sent in a supplemental submission.

Event Description

It was reported by the edwards field representative that there were inaccurate values noted during patient use with the swan ganz module.There were low ci values that displayed.The physician noted the ci values and did not believe that they were correct values being displayed.The patient was healthy and 6'5" in height.The procedure being performed was knee surgery.The physician did not treat off the inaccurate values that displayed, there was no inappropriate patient treatment administered.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.H3 other text : product not received.

• Brand Name: HEMOSPHERE SWAN GANZ MODULE
• Type of Device: SWAN GANZ MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 12393636
• MDR Text Key: 268994240
• Report Number: 2015691-2021-04936
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• 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 Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEMCSM10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1