MAUDE Adverse Event Report: COVIDIEN 3010188-020 QC RTS 1/P 10/B 50; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	PM20003
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that they received a report of delamination from the field on pm20003.
Additional Manufacturer Narrative
The device history records (dhrs) were reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The set was made between november 05th and november 07th, 2019.There were no physical samples received for this complaint.However, a photo of the electrodes was provided, which shows the gel peeled from the center of the electrode.A corrective and preventative action has been initiated to further investigate and address the reported issue.We will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: 3010188-020 QC RTS 1/P 10/B 50
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12470273
• Report Number: 1219103-2021-00339
• Device Sequence Number: 5337692
• Product Code: MKJ
• UDI-Device Identifier: 00721902195037
• UDI-Public: 00721902195037
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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 Model Number: PM20003
• Device Catalogue Number: PM20003
• Device Lot Number: 930852
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown