MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AV-TOCO TOCO+ TRANSDUCER

Model Number	M2735A
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the reading of the av-toco toco+ transducer is incorrect.The device was not in clinical use at the time of the event.No adverse event or patient harm was reported.
Additional Manufacturer Narrative
A quote has been provided to the customer for a replacement transducer.The quote has not yet been accepted.Reporting institution phone (b)(6).
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer and provided a quote for a replacement transducer to the customer.The quote has not been accepted by the customer.Based on the information available, philips was unable to replicate the reported problem.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: AV-TOCO TOCO+ TRANSDUCER
• Common Device Name: AV-TOCO TOCO+ TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 20842716
• Report Number: 9610816-2024-000934
• Device Sequence Number: 8039410
• Product Code: HGM
• UDI-Device Identifier: 00884838002715
• UDI-Public: (01)00884838002715
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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 Model Number: M2735A
• Device Catalogue Number: M2735A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown