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 Information (3190)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event 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.

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
• 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
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7404690
• MDR Text Key: 104680853
• Report Number: 3006451981-2018-00262
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 10884521081826
• UDI-Public: 10884521081826
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1