MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON US TRANSDUCER

Model Number	M2736A
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the avalon us transducer indicating there was a difference in value.It is unknown if the device was in use at time of event, and there was no adverse event 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.E1: (b)(6).
Additional Manufacturer Narrative
A philips field service engineer (fse) went onsite to evaluate the device with instruction by a philips product support engineer (pse).The fse tested the transducers, checked if they were working correctly, and if they had been updated to the newest rev.L.01.05.Results showed the transducers were updated to l.01.05 and they were working to specification.The fse confirmed the ultrasound transducer functional test had already been performed as mentioned in the service guide (sg).The fse noted there were no error messages and the rate was good.The fse verified there was no physical damage to be seen.There were two reported signals generated using l.01.05 transducers; and they were the shift from rcf 2 to +20 on the trace, otherwise known as, the signal that would show a user how to position one transducer correctly and then position the other.This feature made it possible to monitor the same baby at each check-up.The fse made the customer aware of how to connect the transducers properly.The fse reassured the user that the equipment was working to specification.Based on the information available in the case and testing conducted by the philips fse, the customer's allegation could not be confirmed.At the time of the fse's onsite evaluation/testing, the device worked to specification.No further investigation or action is warranted at this time.
Additional Manufacturer Narrative
H6 codes (evaluation results code grid and the conclusion code grid) corrected to align with h10 of previous follow up report.

• Brand Name: AVALON US TRANSDUCER
• Common Device Name: AVALON US 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: 20413958
• Report Number: 9610816-2024-00689
• Device Sequence Number: 8257923
• Product Code: HGM
• UDI-Device Identifier: 00884838002722
• UDI-Public: (01)00884838002722
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/10/2024

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: M2736A
• Device Catalogue Number: M2736A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 12/09/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/09/2024; 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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