MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS REVEAL; RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)

Model Number	9525
Medical Device Problem Code	Cut In Material (2454)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Verified complaint of "exposed copper wire".The power cord was examined and the outer shielding contains a cut mark and the fibers are shredded.
Additional Manufacturer Narrative
N evaluation of the scd 700 was performed and the customer states ¿exposed copper wire.¿ the unit was triaged and the customer¿s reported condition was confirmed.The power cord was examined and the outer shielding contains a cut mark and the fibers are shredded.The potential root cause is customer misuse due to running over the cord with hospital bed or the procedure used to unplug the unit.Device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.A review of the device history record shows that this unit was manufactured and was released meeting all manufacturing specifications.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.

• Brand Name: REVEAL
• Common Device Name: RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 7404690
• Report Number: 3006451981-2018-00262
• Device Sequence Number: 13757177
• Product Code: MXC
• UDI-Device Identifier: 10884521081826
• UDI-Public: 10884521081826
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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: Health Professional
• Device Expiration Date: 02/12/2014
• Device Model Number: 9525
• Device Catalogue Number: 9525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1