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

Model Number M2736A

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2022

Event Type  malfunction  

Event Description

The customer reported that their transducer was not tracing a fetal heart rate appropriately.The device was in clinical use but no patient or user were harmed.

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.

Event Description

Problem statement: the customer reported need bench repair: not tracing fetal heart rate appropriately.There was no reported patient impact / injury.Complaint evaluation: a service quotation has been provided to the customer.However, customer declined remote support and service quotation is canceled.Customer resolution and conclusion: a service quotation has been provided to the customer.However, customer declined remote support and service quotation is canceled.The device remains at the customer site, and no subsequent calls have been logged for this device/issue.No further action or investigation is warranted based on the available information at the time of complaint closure.Patient/user involvement: was the device being used on a patient at the time of the event, including for the purposes of diagnosis? unknown.Was there any adverse event to the patient or user? if yes, describe? no.If there was an adverse event, did the device cause or contribute to the adverse event, and how? there was no adverse event or patient harm reported.

• Brand Name: AVALON US TRANSDUCER
• Type of Device: 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15625648
• MDR Text Key: 301934412
• Report Number: 9610816-2022-00527
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838002722
• UDI-Public: 00884838002722
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2736A
• Device Catalogue Number: M2736A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1