MAUDE Adverse Event Report: CARDINAL HEALTH KENDALL; CABLE, ELECTRODE

Model Number 33103

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 02/22/2020

Event Type  malfunction  

Event Description

Electrocardiogram wires are intermittently cutting off displaying asystole and no respiratory rate.Then will return to normal display.Manufacturer response for disposable cable and lead wire system, kandall (per site reporter).Device sent for evaluation.

• Brand Name: KENDALL
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): CARDINAL HEALTH; 15 hampshire street; building 5; mansfield MA 02048
• MDR Report Key: 9817869
• MDR Text Key: 182991885
• Report Number: 9817869
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 33103
• Device Catalogue Number: 33103
• Device Lot Number: 038480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1