MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC AV-TOCO TOCO+ TRANSDUCER

Model Number	453564453331
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter institution phone number (b)(6).A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The sensor sizzles and has difficulty stabilizing.It is unknown if the device was in use at the time of the event, no adverse event to patient was reported.
Additional Manufacturer Narrative
The customer reported that the transducer did not behave as expected.The customer ordered a replacement transducer to resolve the issue.There was no troubleshooting performed by philips.Because of this, we are considering this to be a malfunction of insufficient information and the device cause to be unknown.H3 other text : device not available.
Event or Problem Description
The customer reported: "the sensor sizzles and has difficulty stabilizing." there was no reported patient/user injury.

• Brand Name: AV-TOCO TOCO+ TRANSDUCER
• Common Device Name: AV-TOCO TOCO+ TRANSDUCER
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; b1-3/d6; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; b1-3/d6; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15348045
• Report Number: 9610816-2022-00474
• Device Sequence Number: 4529640
• Product Code: HGM
• UDI-Device Identifier: 00884838002715
• UDI-Public: 00884838002715
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• 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: 453564453331
• Device Catalogue Number: 453564453331
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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