MAUDE Adverse Event Report: COVIDIEN KENDALL; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Model Number 31319281

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Sudden Cardiac Death (2510)

Event Date 04/05/2017

Event Type  Death  

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 reported, during the procedure they had a rhythm to deliver the shock and when they delivered the shock, instead of reading the rhythm, it went to dashes.The patient went into cardiac arrest and died.Later, they smelt a burnt smell noticing the wire was burnt.

Manufacturer Narrative

Submit date: 1/24/2017 an investigation of the reported condition was performed.A device history record (dhr) review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.Because no sample was returned with this complaint, no physical product examination was possible; therefore, the reported complaint issue could not be confirmed.Had a sample been received, it would have been evaluated against the established product requirements.If a sample is received at a later date this complaint will be reopened for investigation.A probable root cause could not be determined because no samples were submitted to examine for the reported complaint issue and the complaint could not be confirmed.Without a sample that displays the reported condition or a sample in which the reported condition can be duplicated, the root cause cannot be positively attributed to a product design or manufacturing problem.Current manufacturing practices require production to be sampled and inspected through a series of functional and visual testing to ensure good connectivity and shock delivery.Functional testing performed on this product includes but is not limited to electrical testing, energy transmission testing, gel weight measurements, pull force testing, and residual monomer testing.Likewise, visual inspections are performed where construction, alignment, packaging and labeling of product are examined to ensure all product requirements are met prior to release.Production employees also perform 100% visual inspection as part of manufacturing requirements.There have been no design changes to this product within the past year that would contribute to any increased probability for the reported complaint issues.Since this complaint is unconfirmed and no complaint trend exists and a specific root cause for the occurrence cannot be identified, no corrective action is required at this time.This complaint will be recorded for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KENDALL
• Type of Device: DEFIBRILLATORS, AUTOMATIC, EXTERNAL
• Manufacturer (Section D): COVIDIEN; 215 herbert street; gananoque,on K7G 2 Y7; CA K7G 2Y7
• Manufacturer (Section G): COVIDIEN; 215 herbert street; gananoque,on K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6540988
• MDR Text Key: 74308229
• Report Number: 9681860-2017-05006
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2017
• Device Model Number: 31319281
• Device Catalogue Number: 31319281
• Device Lot Number: 535763X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2017
• Date Device Manufactured: 12/18/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death