MAUDE Adverse Event Report: COVIDIEN 1310P MEDITRACE 2/PK 20/CA; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	31319281
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 the metal was separate of the gel pad.

• Brand Name: 1310P MEDITRACE 2/PK 20/CA
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): COVIDIEN; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• MDR Report Key: 10359741
• Report Number: 9681860-2020-00513
• Device Sequence Number: 3162630
• Product Code: MKJ
• UDI-Device Identifier: 20884527008428
• UDI-Public: 20884527008428
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

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: 31319281
• Device Catalogue Number: 31319281
• Device Lot Number: 009201X
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/03/2020
• Patient Sequence Number: 1