MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PEDIASAT OXIMETRY CATHETER, PRESEP OLIGON OXIMETRY CATHETER; CATHETER, OXIMETER, FIBER-OPTIC

Model Number MODEL UNKNOWN

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Manufacturer Narrative

It was further informed that the device was not available for evaluation since this complaint came from a confidential customer feedback survey and the hospital was unknown.Engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.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 per customer feedback in survey regarding these oximetry, eocvc, pediasats, the measurements were not always reliable.The agreement with invasive measurement may be identical but sometimes it is suddenly not.Patient demographics not available.No further information could be obtained as the hospital information is confidential.There was no allegation of patient injury reported.The device was not available for evaluation.

Manufacturer Narrative

Updated section h6 (component code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusion).The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.Based on further engineering investigation, the pediasat units go through optic and calibration inspection process as part of the manufacturing process.

• Brand Name: PEDIASAT OXIMETRY CATHETER, PRESEP OLIGON OXIMETRY CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17031232
• MDR Text Key: 316231890
• Report Number: 2015691-2023-13322
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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