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

Model Number	M2736A
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the fetal heart waveform was abnormal.The device was in clinical use at time of event, no adverse event was reported.
Additional Manufacturer Narrative
A philips field service engineer (fse) went onsite to evaluate the device in question.Functional testing was performed and results showed that after the probe was turned on, there is no reaction.The appearance of the probe was aged and damaged.The device screen reports an error: the probe was determined to be faulty.Based on the information provided in the case and by the fse, the cause of the reported problem was confirmed to be the worn out probe.The probe was replaced and scrapped due to its age.After the probe replacement, the unit returned to specification.No further investigation or action is warranted at this time.Reporting institution phone e1; (b)(6).

• 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: 19533377
• Report Number: 9610816-2024-00336
• Device Sequence Number: 12656292
• Product Code: HGL
• UDI-Device Identifier: 00884838002722
• UDI-Public: (01)00884838002722
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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: 05/15/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2016
• 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