MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PKG ASSY, SWAN GANZ; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEMSGM10

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

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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.

Event Description

It was reported that bt measurements were unstable, and co measurement stopped during use.The bt values dropped to 2.6 celsius degree and then rose to 36.3 celsius degree in a short period of time.Additionally, error messages of light out of range and fault oximetry cable disconnected were displayed on the monitor.70cc cable passed the cable test.The issues were resolved by swapping the monitor and swan ganz module.No patient injury was reported.

Manufacturer Narrative

The reported event could not be confirmed.When sgm was received, the device label was noticed to have been removed.This allows access for the device to be opened.The device was opened to verify if the original boards were still installed, and that the flex cable was connected correctly.The sgm was reassembled and installed into a known working hem1.Attached it to a cco simulator and began monitoring.Monitored the cco simulator for over 2hours with no faults.The readings never stopped, and stayed stable.No parts of this sgm are suspect.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

A device history record review was completed and documented that device met all specifications upon distribution.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.

• Brand Name: PKG ASSY, SWAN GANZ
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16966013
• MDR Text Key: 315747273
• Report Number: 2015691-2023-13076
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2023

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 Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Device Lot Number: 13621964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 06/27/2023; 07/31/2023
• Supplement Dates FDA Received: 07/06/2023; 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1