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

Model Number	22550R-
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
The customer reported that there was a break in the defib pad wire and there was a burn on the blanket.There was no patient harm.
Additional Manufacturer Narrative
The device history records (dhrs) were reviewed, this includes all finished product and raw material records, 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.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.Inspection criteria for this product includes 100% fgwt (finished good wire testing) testing.Fgwt testing is performed on every set of product manufactured to ensure there are no breaks in the wire.There were no failed fgwt tests throughout the production run.For lot 025120x (b)(4) sets were made between 27-august-2020 and 10-sept-2020.Samples were received in the form of sixty samples of 22550r lot 025120x.The original complaint sample and then 59 more samples were received.Visual inspections were performed on all 60 samples.The original complaint sample has a small hole near the connector.The remaining 59 samples were inspected with no defects found.Fgwt testing was performed on the original complaint sample with a failing result.The reaming returned samples were tested with no failing values.From a root cause analysis perspective, a review of our process failure mode effects analysis for the terminator machine details the most likely manufacturing causes related to a wire defect which could result in a break in the wire as an issue of damage during the manufacturing process such as during the wire cutting process, the crimping process prior to molding the connector and during the slug creation process (cutting the end of the insulation to allow for the end of the wire to be exposed for creating the final product.During production there is a test performed referred to as fgwt testing (finished good wire testing) which is a test that sends high voltage through the wire to create potential and screen any amperage that would leak to the return line.This test runs current through the wire to determine if there is a break in the wire.As there were no failures during production it is not likely one of the previously mentioned potential defects are the cause.There is a potential that during the packing process the wire caught on something resulting in the wire being pulled and causing a break or cut.There is the potential during unpacking of the product the wire was caught on something resulting in a cut or break in the wire.Either of these could result in current escaping the insulation resulting in the complaint as stated.While there are possible causes associated with the manufacturing process there are controls in place to mitigate these causes.The results of the manufacturing facility investigation were unable to confirm any potential root causes associated with the manufacture of product which would have contributed to the reported condition.No corrective or preventative actions are necessary.We will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: CADENCE PHYSIO QC ADULT RTS
• Common Device Name: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 10848728
• Report Number: 1219103-2020-00308
• Device Sequence Number: 14325160
• Product Code: DRO
• UDI-Device Identifier: 20884527022332
• UDI-Public: 20884527022332
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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
• Operator of Device: No Information
• Device Model Number: 22550R-
• Device Catalogue Number: 22550R-
• Device Lot Number: 025120X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 01/09/2021
• Patient Sequence Number: 1