MAUDE Adverse Event Report: COVIDIEN 1410Z MEDITRACE 2/P 20/CA; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 31469219

Device Problems Failure to Deliver Energy (1211); Arcing of Electrodes (2289)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 10/18/2019

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 that during a synchronized cardioversion, the defibrillator pad did not deliver shock but instead sparked and burned the patient.The patient was given minor nursing treatment for a first degree burn and was discharged from the hospital.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were four photos submitted with this complaint.Review of first photo showed one pouch confirming the lot & product code with the lot & product code submitted with this complaint.The second photo showed a picture of the defib pads folded over onto itself with the cables.The third picture showed the complete view of the cables and the fourth picture was both pads and pouch.The photos did not reveal the patient¿s extent of the burn from the defibrillator pad.One set of used defib electrodes was returned for evaluation with one open pouch.The set of electrodes visually showed no abnormalities identified to deem the electrode dysfunctional or impossible to use.The set of electrodes was subjected to electrical properties testing and simulated defibrillation testing according to finished product release requirements.All test results passed and met product requirements with typical results.The returned sample does not indicate any construction or during testing that may have caused a spark as per the customer¿s feedback therefore, the reported condition of malfunction or sparked is not confirmed.Current manufacturing practices require production to be sampled and inspected through a series of functional and visual testing based on valid aql sampling plans to ensure good connectivity and shock delivery.Functional testing performed on this product includes but is not limited to electrical properties testing, energy transmission by simulating defibrillation testing, gel weight measurements, pull force testing, and residual monomer testing.Likewise, visual inspections are performed based on aql sampling 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 could have contributed to the alleged complaint incident.Since this complaint is unconfirmed, no further corrective action is required at this time.This complaint will be recorded for tracking and trending purposes.

• Brand Name: 1410Z MEDITRACE 2/P 20/CA
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): COVIDIEN; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• MDR Report Key: 9260267
• MDR Text Key: 219165401
• Report Number: 9681860-2019-00508
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 20884527010315
• UDI-Public: 20884527010315
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 31469219
• Device Catalogue Number: 31469219
• Device Lot Number: 912612X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/21/2019
• Patient Sequence Number: 1