MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON TOCO+ MP TRANSDUCER

Model Number	867245
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	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.(b)(6).
Event or Problem Description
It was reported the avalon toco+ mp transducer does not measure accurately.The device was in clinical use at the time of the event.No adverse event or patient harm was reported.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
The device was not in clinical use at the time of the event.No adverse event or patient harm was reported.
Additional Manufacturer Narrative
The inaccurate measurement occurred during the testing of the avalon toco+ mp transducer by the customer.A philips field & remote service engineer tested the transducer, but was unable to duplicate the reported issue; the transducer passed the functional test.The philips field & remote service engineer reached out to product support engineering (pse) with a request for additional information about the testing procedure of the transducer.Product support engineer (pse) reached out to research & development (r&d) for more information about the possible root cause of the deviation in measurement.R&d stated that the test set up includes several components: the manometer, the transducer, the iup adapter cable and the reading itself by the person who performs the test.Measuring inaccuracies are possible with each of these components.The result of the testing by the philips field & remote service engineer is a pass, which means the inaccuracy is possibly caused by an incorrect test set up by the customer.It is unclear if the issue was caused due to the testing set up or due to the transducer.Therefore, a replacement transducer was provided to the customer.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: AVALON TOCO+ MP TRANSDUCER
• Common Device Name: AVALON TOCO+ MP 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: 20294443
• Report Number: 9610816-2024-00637
• Device Sequence Number: 7171149
• Product Code: HGM
• UDI-Device Identifier: 00884838093188
• UDI-Public: (01)00884838093188
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2025

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: 867245
• Device Catalogue Number: 867245
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 01/30/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 01/08/2025; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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