MAUDE Adverse Event Report: COVIDIEN 3202674-005 REDIPAK 1P 10B 50C; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number PM20022

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

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 gel on the electrode appeared to be peeling off.

Manufacturer Narrative

The device history records (dhrs) were reviewed for the electrode and all subassembly parts, 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 for the released product.Samples were received in the form of 8 sealed foil pouches.Visual inspection of the product shows a label clearly stating ¿sample not for clinical use¿ these are not usable product.The usage of the product depends on the packaging instructions.No abnormal odors were detected and liner peels from product with no gel delamination present.From a root cause analysis perspective, product labeled ¿sample not for clinical use¿ is not intended for use and should not be used.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 deemed necessary at this time.We will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: 3202674-005 REDIPAK 1P 10B 50C
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 9224694
• MDR Text Key: 163643154
• Report Number: 1219103-2019-00240
• 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,user f
• 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: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PM20022
• Device Catalogue Number: PM20022
• Device Lot Number: 724844
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/09/2019
• Patient Sequence Number: 1