MAUDE Adverse Event Report: MA028 MA-CHICOPEE 3202380-006 AED PEDI 1/P 25/C; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number PM20114

Device Problem Peeled/Delaminated (1454)

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

Event Date 10/09/2019

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 the electrode exhibited delamination.

Manufacturer Narrative

The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition as described by the customer.It was noted during product history review the expiration date for the product is 2019-03-24.The samples were received in the form of one pouch of product.Visual inspection on the pouch shows wrinkling.The labels appear torn and stuck on with tape.Inspection of the labeling shows the expiration date verified as expired product.The product was removed, and a slight odor was detected from the pouch.Electrodes were peeled from the liner and gel delamination was found.From a root cause analysis perspective, the product is past the expiration date.This could be both the cause of the slight odor and the gel delamination.Gel delamination is also possible if the defib electrodes are not properly stored.As indicated on the product packaging proper storage and usage of the electrodes is critical to the performance of the gel.The electrodes should be stored in their sealed protective pouch in a cool, dry place and out of direct sunlight.Do not open package until ready for use.Do not bend, fold, or puncture the packaging.Improper storage conditions and/or handling of the product may compromise gel properties prior to the expiration.As a result of the investigation, it was not possible to confirm any potential root causes associated with the manufacture of product which would have contributed to the reported condition.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 3202380-006 AED PEDI 1/P 25/C
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): MA028 MA-CHICOPEE; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 9207660
• MDR Text Key: 168619735
• Report Number: 1219103-2019-00239
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PM20114
• Device Catalogue Number: PM20114
• Device Lot Number: 628111
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/09/2019
• Patient Sequence Number: 1