MAUDE Adverse Event Report: COVIDIEN KENDALL; CABLE, ELECTRODE

Model Number 33541

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

The customer stated the telemetry was reading sustained v-tach, however upon connecting patient to the defibrillator, the patient was noted to be in a normal sinus rhythm.The telemetry box continued to show sustained v-tach.The telemetry box, adapter, and lead wires were changed on the patient showing sinus rhythm.

Manufacturer Narrative

An investigation of this reported condition was performed by the manufacturing facility.A device history record (dhr) review of the affected lots had been completed and it confirmed that the product was produced accomplishing quality requirements and released according to established procedure.There were no actual samples returned for evaluation thus the examination/analysis of the reported condition could not be performed.Based on the investigation and analysis, the root cause could not be identified, thus no corrective/preventive action will be taken at present.This complaint will be used for trending purpose.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KENDALL
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6667895
• MDR Text Key: 78566601
• Report Number: 1282497-2017-05188
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 33541
• Device Catalogue Number: 33541
• Device Lot Number: 278428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1