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

Model Number 33527T

Device Problems Break (1069); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported the adapter is breaking and the telebox that is using the adapters gets hot.There was no patient harm.

Manufacturer Narrative

After further review of the complaint details it was determined that this report was submitted in error as the incident does not meet the mdr regulation requirements of a reportable event.

• Brand Name: DATASCOPE PANORAMA AD TELE
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11307707
• MDR Text Key: 231170213
• Report Number: 1282497-2021-09898
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 10884521212527
• UDI-Public: 10884521212527
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 33527T
• Device Catalogue Number: 33527T
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/02/2021
• Patient Sequence Number: 1