MAUDE Adverse Event Report: COVIDIEN CADENCE PHILIPS BARREL PRECONN; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 22661PC

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 01/18/2019

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 reports they were able to see that the wires extending from the defibrillation pad were exposed coming out of the package.Additional information received from the customer on 15-mar-2019 stated that the actual metal wiring under the plastic coating could be visualized.

Manufacturer Narrative

Additional information d 4 : unique identifier number added.Evaluation summary h 3: (device evaluated by mfr).The device history record (dhr) for the production lot number was reviewed for any problems and disparities.All process parameters, product, raw materials, and sub-assembly components met the required acceptance criteria to completely satisfy the manufacturing requirements per the product specification.No adverse conditions, special circumstances, or events were documented.One electrode was received for evaluation.Visual inspection shows the insulation at the ¿football¿ section of the wire is broken.The section broken is the part of the wire that is exposed during packaging and storage.A close-up view shows the break in the wire is ragged as if it was pulled out.Dielectric testing on the wire to verify it would result in a failure could not be performed due to the pouch being attached to the product.The material of the pouch attached to the wire would result in a dielectric failure.The results of the manufacturing facility investigation were unable to attribute any root causes associated with the manufacture of the product which would have contributed to the wire detaching from the electrode pad.Each electrode set is subjected to continuity testing during assembly, finished good wire testing (dielectric testing of the wire to detect breaks in insulation), & visual inspection of the assembly (including the wire) prior to packaging in the final pouch.Any product not meeting assembly requirements would be culled out as unacceptable.Based upon the investigative details and the root cause evaluation, no further corrective or preventative actions will be taken at this time in relation to the damaged wire insulation.The manufacturing site will continue to trend this condition for future occurrences as part of the complaint review process.

• Brand Name: CADENCE PHILIPS BARREL PRECONN
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 8425981
• MDR Text Key: 138971396
• Report Number: 1219103-2019-00227
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22661PC
• Device Catalogue Number: 22661PC
• Device Lot Number: 802906X
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 03/15/2019
• Supplement Dates FDA Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1