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

Model Number 9525

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Upon triage the service tech found the pump to have a power cord damaged with exposed copper.

Manufacturer Narrative

Scd 700 unit was received in fi with no active gch for the unit with a complaint of ¿pump has a damaged case¿.The complaint was verified as it was found the unit had a power cord damaged with copper wire exposed.One kendall scd express sequential compression device was received for failure analysis.Both the reported and observed symptoms were verified.Upon a physical inspection of the device, the handle of the front enclosure was observed to be broken and the power cord was observed to be damaged with exposed copper wire.The potential root causes are customer misuse due to the procedure used to unplug the unit and the procedure of wrapping of the cord around the bed hook.Device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.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
• Type of Device: 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: 7540166
• MDR Text Key: 109114497
• Report Number: 3006451981-2018-00393
• Device Sequence Number: 1
• Product Code: MXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2011
• Device Model Number: 9525
• Device Catalogue Number: 9525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Date Manufacturer Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1