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

Model Number	AVALON US TRANSDUCER
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fetal heart monitor showed 135 times/min, but the sound was obviously rapid, and then carried out b-ultrasound examination, showing the fetal heart rate of 263 times/min, and tested with the fetal heart monitor, showing that the fetal heart rate was still about 135 times/min.This was resulting in a doctor's diagnosis error, emergency to the operating room.Patient / user harm was reported without further details.The device was in use on a patient.There was report of patient or user harm.
Additional Manufacturer Narrative
E1: reporter institution phone number (b)(6).E1: reporter phone # (b)(6).A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Multiple attempts were made to gather additional info (like what exactly happened to the patient), but only limited information was provided.It turned out that the patient recovered, but no further infor regarding the event has made been available.Based on the information available and the testing conducted, the cause of the reported problem "inaccurate fetal heart rate measurement" was a defective m2736a avalon transducer.The customer replaced the transducer to resolve the issue.
Event or Problem Description
It was reported that the fetal heart monitor showed 135 times/min, but the sound was obviously rapid, and then carried out b-ultrasound examination, showing the fetal heart rate of 263 times/min, and tested with the fetal heart monitor, showing that the fetal heart rate was still about 135 times/min.This was resulting in a doctor's diagnosis error, emergency to the operating room.Patient / user harm was reported without further details.The device was in use on a patient.There was report of patient or user harm.
Additional Manufacturer Narrative
This record was updated as part of a retrospective review.D2b procode: updated from hgm to hcl per gudid.D4 model #: updated from m2736a to avalon us transducer per gudid.D4 catalog #: updated from m2736a to 989803143691 per gudid.Analysis was performed by hospital service personnel which concluded that the cause of the reported problem was a defective m2736a avalon ultrasound transducer.The reported problem was confirmed with a replacement of the transducer.The initial transducer is not available for failure analysis.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was a faulty avalon us transducer.The issue was resolved by replacing the avalon us transducer and the product was put back in service.Based on the information available and results of additional analysis, no further action is necessary at this time.
Event or Problem Description
Additional information was received which indicated that monitoring continued there and it was clarified there was no patient harm and no medical intervention required due to the reported issue.The patient's status was described as recovered.The users appeared to have recognized the discrepancy in fetal heart rate and double-checked with an ultrasound.

• 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: 18245284
• Report Number: 9610816-2023-00632
• Device Sequence Number: 17919352
• Product Code: HGM
• UDI-Device Identifier: 00884838002722
• UDI-Public: 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,Followup,Followup
• Report Date (Section B): 01/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AVALON US TRANSDUCER
• Device Catalogue Number: 989803143691
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 03/04/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 02/28/2024; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown