MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT; HEMOSPHERE MONITOR

Model Number HEM1

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

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that there were incorrect mean arterial pressure readings with the hemosphere monitor.The facility reported that they had this issue on (b)(6) 2022 and that it had happened previously.Unknown exact occurrence date.Occurrence date will default to (b)(6) 2022.The exact details of the event are unknown.Serial number is unknown.There will be no product return.Attempted to obtain any additional information available, but there has been no response.There was no patient harm or injury reported.There was no inappropriate patient treatment reported.Patient demographics are unknown.

Manufacturer Narrative

The product serial number is unknown; therefore, there is no product return.The device service history record review could not be completed as the serial number is unknown.The udi number is unknown.The other event that occurred at this facility will be reported in an mdr submission and when that submission number is available it will be sent in a supplement report.

Manufacturer Narrative

There is no product return as the serial number of the unit is unknown to identify the unit.The submission number for the other event that is linked to this facility is (b)(4).

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614
• MDR Report Key: 13259138
• MDR Text Key: 285051182
• Report Number: 2015691-2022-03392
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

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 Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/20/2022
• 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