MAUDE Adverse Event Report: ARJO INC. FLOWTRON EXCEL; SLEEVE, LIMB, COMPRESSIBLE

Model Number 247001

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2018

Event Type  malfunction  

Event Description

Strain relief broken.Not working properly/broken.

• Brand Name: FLOWTRON EXCEL
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): ARJO INC.; 12625 wetmore road, suite 308; san antonio TX 78247
• MDR Report Key: 7845524
• MDR Text Key: 119217066
• Report Number: 7845524
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 247001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1