MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE SWAN GANZ MODULE

Model Number HEMSGM10

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

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Attempts have been made to request product return and it has not arrived.Once it has arrived and the evaluation completed a supplemental report will be submitted with the findings.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.The mdr submission number of the hem1 involved will be provided when available.

Event Description

It was reported that there were inaccurate values with the hemosphere instrument and swan ganz module.There were no fault messages reported.It is unknown the inaccurate numbers that displayed and what numbers were expected.The biomed from the facility received a note on the equipment that stated "wrong co numbers".He was not able to contact the user to obtain any additional information.He started up the system successfully and it checked out ok.The patient demographics are unknown.There was no inappropriate patient treatment reported.There was no patient harm or injury reported.

Manufacturer Narrative

Attempts were made to the facility to request product return.It did not arrive for evaluation.There are no evaluation findings available.The medwatch submission number for the sg module involved is 2015691-2021-04843.

• 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: 12363050
• MDR Text Key: 268064150
• Report Number: 2015691-2021-04843
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEM1 INSTRUMENT