MAUDE Adverse Event Report: COVIDIEN KENDALL DL ADAPTER PHILIPS 3 5 LD; CABLE, ELECTRODE

Model Number	33507
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the adapter melted.There were no issues observed with any other products being used with the adapter at the time.There was no patient harm.

• Brand Name: KENDALL DL ADAPTER PHILIPS 3 5 LD
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11557827
• Report Number: 1282497-2021-09998
• Device Sequence Number: 4204238
• Product Code: IKD
• UDI-Device Identifier: 10884527021475
• UDI-Public: 10884527021475
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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: No Information
• Device Model Number: 33507
• Device Catalogue Number: 33507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/23/2021
• Patient Sequence Number: 1