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

Model Number	HEMDPT1000
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 2015691-2023-14833
• Device Sequence Number: 14941287
• Product Code: DQE
• UDI-Device Identifier: 00690103199338
• UDI-Public: (01)00690103199338(11)211016(10)098577
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K180881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/24/2023; 11/15/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/30/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown