MAUDE Adverse Event Report: EDWARDS LIFECIENCES FORESIGHT SENSOR; OXIMETER, TISSUE SATURATION

Model Number 01-07-1101

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.Lot number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

On hold for denisse 08/28 it was reported that during use on right side head of a 7kg patient, this foresight sensor was not reading correctly.The packaging is not available and therefore model and lot number is unknown.Follow-up ongoing for further information.No patient injury has been reported.The product was available for evaluation.

Manufacturer Narrative

Further investigation determined that this is a duplicate complaint.This was previously reported under medwatch 2015691-2020-12193.This complaint will be voided.

• Brand Name: FORESIGHT SENSOR
• Type of Device: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): EDWARDS LIFECIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10467305
• MDR Text Key: 204775549
• Report Number: 2015691-2020-13346
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• PMA/PMN Number: K143675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-07-1101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 7