MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number EVHRS

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for further analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The device history record was reviewed; no related non-conformances were found.There is no escalation is required.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

As reported during evaluation, when the set point was at -40 cm for the hrs pressure test, the measured value was 41 mmhg.The specification range should be between 29 - 33 mmhg.There was no patient involvement.

Manufacturer Narrative

The clearsight heart reference sensor (hrs) was returned for evaluation.The reported issue was not confirmed by the evaluation.The hrs was connected to a clearsight hot mock up system.With the bladder and sensor at the same height, the offset before zeroing was 9 mmhg.The offset after zeroing was 0 mmhg.Normal waveform and blood pressure readings were also able to be acquired.With the bladder at a difference of -40cm from the sensor the reading was 31mmhg.With any hemodynamic monitoring, patient parameters can change quickly and dramatically.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.It is unknown whether any user or procedural factors contributed to this reported event.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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EV1000
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9263492
• MDR Text Key: 188724311
• Report Number: 2015691-2019-04052
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2019

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: Other
• Device Expiration Date: 12/26/2020
• Device Model Number: EVHRS
• Device Catalogue Number: EVHRS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 12/12/2019; 07/23/2020
• Supplement Dates FDA Received: 12/24/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1