MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR ACUMEN IQ SENSOR; ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR

Model Number AIQS85

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inaccurate Information (4051)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when the rep was connecting to a 58 year old patient the sv was reading 110.Later in the case the co increased to 10 and ci to 5.The patients cardiac index/cardiac output displayed a high number on the monitor that did not match the clinical picture of the patient.Troubleshooting was attempted to resolve the issue.There was no allegation of patient injury.

Manufacturer Narrative

The device was not returned for evaluation.Without 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.Further evaluation regarding related quality issues is under investigation.A device history record review was completed and documented that device met all specifications upon distribution.Corrections to the h6 codes device code, investigation findings, and investigation conclusions were made.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: ACUMEN IQ SENSOR
• Type of Device: ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 18311696
• MDR Text Key: 330290956
• Report Number: 2015691-2023-18301
• Device Sequence Number: 1
• Product Code: QAQ
• UDI-Device Identifier: 00690103200942
• UDI-Public: (01)00690103200942(17)250808(11)230809(10)65223453
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AIQS85
• Device Lot Number: 65223453
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR