MAUDE Adverse Event Report: COVIDIEN MEDI-TRACE CADENCE; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 22550A

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states the nurse was shocked while using the product.There was no medical intervention or resulting injuries reported.

Manufacturer Narrative

A review of the device history record was not performed during this investigation as the lot number was not received with the complaint.All device history records are reviewed and approved by quality prior to release of product.Because there was no lot number, a date of manufacture could not be determined.According to the complaint details the electrodes were being returned for evaluation.As of date the investigating/mfg.Site has not received the electrodes for evaluation.Given the information provided in the complaint and its investigation, no root cause could be identified manufacturing related deviations from the required specifications or process.From a potential root cause perspective unrelated to the manufacturing process, defibrillation electrodes can pose a shock hazard to the rescuer.1) the defibrillator delivers up to 360 j of electrical energy.When discharging the defibrillator, do not touch the paddle electrode surfaces or disposable therapy electrodes.2) if a person is touching the patient, bed, or any conductive material in contact with the patient during defibrillation, the delivered energy may be partially discharged through that person.Clear everyone away from contact with the patient, bed, and other conductive material before discharging the defibrillator.3) do not discharge the defibrillator into the open air.To remove an unwanted charge, change the energy selection, select disarm, or turn off the defibrillator.No corrective or preventative actions are necessary at this time as no root cause related to the manufacturing process was identified.We will continue to trend this event for future occurrences as part of the complaint review process.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDI-TRACE CADENCE
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow park dr; chicopee MA 01022 1318
• MDR Report Key: 6921137
• MDR Text Key: 89382816
• Report Number: 1219103-2017-05018
• Device Sequence Number: 1
• Product Code: DRO
• 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: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22550A
• Device Catalogue Number: 22550A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2017
• Patient Sequence Number: 1