MAUDE Adverse Event Report: EDWARDS LIFESCIENCES TRUWAVE; PRESSURE MONITORING SET

Model Number	PX600
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	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested to be returned for product evaluation, however, it has not arrived.Once it arrives and the evaluation completed a supplemental report will be submitted with the findings.The device history record review is pending.Once the results are available they will be submitted in a supplemental report.Additional 510k number, k171996.
Event or Problem Description
It was reported that during use with a truwave pressure monitoring set that the transducer connector was noted to be loose and stripped with an unsealed or loose connection to the lumbar drain.Per the customer, this created inaccurate values.The information was provided through a voluntary medwatch.There was no patient injury reported.
Additional Manufacturer Narrative
No product was returned for evaluation.Without the 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 is some procedural factors may have contributed to the event.An engineering evaluation was completed to assess for any manufacturing related processes which could be correlated to the complaint.No root cause could be identified since no product sample nor objective evidence was provided for investigation.A device history record review was completed and documented that device met all specifications upon distribution.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 the monthly review.

• Brand Name: TRUWAVE
• Common Device Name: PRESSURE MONITORING SET
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 17200 laguna canyon road; irvine CA 92618
• Manufacturer (Section G): EDWARDS LIFESCIENCES DOMINICAN REPUBLIC; parque industrial de itabo; carr sanchez km 18.5
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon road; irvine, CA 92618 ; 9492017706
• MDR Report Key: 21994808
• Report Number: 2015691-2025-03693
• Device Sequence Number: 8312407
• Product Code: DXO
• UDI-Device Identifier: 07460691957060
• UDI-Public: (01)07460691957060(17)250629(11)230630(10)65170575
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142749
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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 Expiration Date: 06/29/2025
• Device Model Number: PX600
• Device Lot Number: 65170575
• Was Device Available for Evaluation?: No
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Unknown