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

Model Number M2736A

Device Problems Incorrect Measurement (1383); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  malfunction  

Event 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.

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 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)
• Type of Device: 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
• MDR Text Key: 302174286
• Report Number: 9610816-2022-00530
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838002722
• UDI-Public: 00884838002722
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• 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?: Yes
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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