MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE SWAN-GANZ MODULE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEMSGM10

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Manufacturer Narrative

The swan ganz module will not be returned for evaluation.Without the return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.The serial number was not provided; therefore, review of the manufacturing records could not be completed.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 part of this monthly review.

Event Description

It was reported that during use of this swan ganz module, the cco value showed up and down in a regular motion.The customer thought that the patient's condition did not lead to this symptom.It is considered that the monitor caused this symptom, not the disposable devices.There was no patient injury reported.The product is not available for evaluation.

Manufacturer Narrative

The hemosphere monitor report number: 2015691-2022-03369.The swan ganz module report number: the 70cc2 cable report number: 2015691-2022-03371.

Manufacturer Narrative

Additional information was received that an engineer for philips visited the site and the main board of philips intellibridge ec10 patient monitor module was replaced.It was confirmed through the medical engineer that both the data transmission issue and fluctuation in cco values were solved by replacing the main board of philips intellibridge ec10.The customer confirmed these issues were related to the philips intellibridge ec10 and not an edwards device; therefore, this complaint is no longer considered as reportable.

• Brand Name: HEMOSPHERE SWAN-GANZ MODULE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 13256156
• MDR Text Key: 284998756
• Report Number: 2015691-2022-03370
• 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,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1