MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON CABLELESS TOCO+ MP TRANSDUCER

Model Number	866075
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the unit overheated and burned the patient.The patient required treatment.
Additional Manufacturer Narrative
Reporter phone number: (b)(6).Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
H3 other text : device not returned to philips.
Event or Problem Description
It was reported that the avl-toco transducer heated up and caused a burn on the patient.The device was in use monitoring a patient at the time of the reported event.The incident caused the patient to be injured and to require treatment.Multiple good faith efforts were made to obtain additional information associated with this complaint evaluation.There has been no response from the customer.The cause for the reported issue could not be determined.A replacement avalon cableless toco+ mp transducer was delivered to the customer and consumed.Based on the available information, the cause for the reported issue could not be determined.No further investigation or action is warranted.

• Brand Name: AVALON CABLELESS TOCO+ MP TRANSDUCER
• Common Device Name: AVALON CABLELESS TOCO+ MP 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, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 15691176
• Report Number: 9610816-2022-00538
• Device Sequence Number: 7337896
• Product Code: HGM
• UDI-Device Identifier: 00884838034235
• UDI-Public: 00884838034235
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 866075
• Device Catalogue Number: 866075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2016
• 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: Female