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

Model Number 866075

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/30/2022

Event Type  Injury  

Event Description

The customer reported that the unit overheated and burned the patient.The patient required treatment.

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.

Manufacturer Narrative

H3 other text : device not returned to philips.

Event 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
• Type of Device: 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
• MDR Text Key: 302599245
• Report Number: 9610816-2022-00538
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838034235
• UDI-Public: 00884838034235
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 10/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866075
• Device Catalogue Number: 866075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female