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

Model Number 22550PC

Device Problems Loss of or Failure to Bond (1068); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested but to date has not yet been received.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 an emergency procedure, the wire/conduction plate broke upon opening of the packaging with subsequent malfunction of the product.The plate had to be urgently changed.

Manufacturer Narrative

A review of the device history record (dhr) for lot no.822923x indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to, material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.The customer returned the defib electrode with the detached wire.The original pouch was returned with the defib electrode set, which indicated lot number 822923x.A visual evaluation of each defib electrode pads within the set was performed.The pads were reviewed for compromised wire and placement within the electrode pads.There was no damage to the wire lead set.All components were present and were constructed per the product specifications.No abnormalities were observed.The electrode pad that was still intact was subjected to parallel pull test.The results of the test were within the acceptance criteria.The results of the manufacturing facility investigation were unable to attribute any potential root causes associated with the manufacture of 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, & visual inspection of the assembly (including the pad) prior to packaging in the final pouch.Any product not meeting assembly requirements would be culled out as unacceptable.From a potential root cause perspective, the damage to the defib electrode/wire detaching may have occurred due to the manner in which the defib electrode set was removed from the packaging or handling by the user (i.E.Forcefully pulled pad of liner by wire).Care should be taken when removing the pad from the liner.The product should be stored in a manner which does not expose the product to being crushed or folded.The product should not be stored under heavy objects as it may damage the product.The product should not be used if the pouch is damaged.The reported customer complaint could not be confirmed.A root cause could not be determined.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.This complaint will be utilized for tracking and trending purposes.

• Brand Name: CADENCE PHYSIO PRECONNECT
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 8408386
• MDR Text Key: 138401340
• Report Number: 1219103-2019-00226
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22550PC
• Device Catalogue Number: 22550PC
• Device Lot Number: 822923X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1