MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMDPT1000; HEMOSPHERE PRESSURE OUT CABLE

Model Number HEMDPT1000

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

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

Event Date 07/06/2023

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned for evaluation.When it arrives and the product evaluation has been completed, a supplemental report will be submitted.The device history review was completed.And all inspections passed with no nonconformances.

Event Description

It was reported, that the hemdpt1000 had a discrepancy to the bedside monitor during use.The systolic diastolic and mean arterial pressure were 20 points different from the phillips monitor.The hemosphere was reading lower consistently, for 30 or more minutes.No error messages were present.They exchanged cuffs cords and double checked connections.There was no patient harm.Patient demographics were unavailable.

Manufacturer Narrative

A supplemental mdr is being submitted due to no product return.Sections g6, h2, h6: type of investigation, investigation findings, investigation conclusions and have been updated.After several attempts made to request product return from the customer, there was no response received.The product was not returned for evaluation.If the product does arrive, a supplemental report will be submitted with the evaluation findings.

Manufacturer Narrative

A supplemental mdr is being submitted due to product evaluation findings.The hemdpt1000 was received for product evaluation.A visual inspection did not find any visible physical damage.The suspect unit was connected to a known good working system.The unit passed on the cirris cable tester.There was no defect found.

• Brand Name: HEMDPT1000
• Type of Device: HEMOSPHERE PRESSURE OUT CABLE
• 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 ; 9492500294
• MDR Report Key: 17393713
• MDR Text Key: 319774659
• Report Number: 2015691-2023-14833
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103199338
• UDI-Public: (01)00690103199338(11)211016(10)098577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2023

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 Operator: Health Professional
• Device Model Number: HEMDPT1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/24/2023; 11/15/2023
• Supplement Dates FDA Received: 08/30/2023; 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2021
• 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