MAUDE Adverse Event Report: COVIDIEN DATASCOPE PANORAMA AD TELE; CABLE, ELECTRODE

Model Number	33527T
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" into the datascope panorama telebox.The telebox was too hot to touch, so pliers were used to extract the adapter.Additional information was received stating that the telebox was used during a normal ekg monitoring procedure.There was no problem seeing it or reading the display, but it did cause central tele to go check on it due to irregular rhythm.There was no injury related to this issue.It was also stated that it is not known which device got hot first, the telebox or the adapter.The box was so hot that they had to pull the adapter out of the box.They do not know the reason why it overheated.

• Brand Name: DATASCOPE PANORAMA AD TELE
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11171892
• Report Number: 1282497-2021-09846
• Device Sequence Number: 11454747
• Product Code: IKD
• UDI-Device Identifier: 10884521212527
• UDI-Public: 10884521212527
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2021

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: 33527T
• Device Catalogue Number: 33527T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/14/2021
• Patient Sequence Number: 1