MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON US TRANSDUCER (M2736A)

Model Number	M2736A
Medical Device Problem Codes	Incorrect Measurement (1383); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the ctg (cardiotocograph) machine spontaneously turned itself back on and then recorded a trace which was tachycardic at 180bpm for over 90mins.The device was not in use at the time of the event as the monitor was not hooked up to the patient, no patient impact.
Additional Manufacturer Narrative
Reporting address state (b)(6).Reporter institution phone number (b)(6).Reporter phone number (b)(6).A follow up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported the ctg (cardiotocograph) spontaneously turned itself back on and then recorded a trace which was tachycardic at 180bpm for over 90mins.The device was not in use at the time of the event as the device was not hooked up to the patient, no patient impact.A philips field service engineer (fse) went onsite to evaluate the device in question.Based on the information available and the testing conducted, the cause of the reported problem was a defective transducer.The reported problem was confirmed.The customer was provided with a replacement transducer to resolve the issue.

• Brand Name: AVALON US TRANSDUCER (M2736A)
• Common Device Name: AVALON US TRANSDUCER (M2736A)
• 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, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 15648102
• Report Number: 9610816-2022-00530
• Device Sequence Number: 17651431
• Product Code: HGM
• UDI-Device Identifier: 00884838002722
• UDI-Public: 00884838002722
• 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,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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: 09/28/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 02/07/2023
• 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
• Patient Sex: Unknown