MAUDE Adverse Event Report: ARJOHUNTLEIGH AB FLOWTRON EXCEL DVT PUMP; SLEEVE, LIMB, COMPRESSIBLE

Device Problems Break (1069); Detachment of Device or Device Component (2907); Noise, Audible (3273)

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

Event Date 05/07/2019

Event Type  malfunction  

Event Description

Device keeps making chirping sounds.Found that air tube connector was broken off in manifold valve.Noted to be a mechanical failure.

• Brand Name: FLOWTRON EXCEL DVT PUMP
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): ARJOHUNTLEIGH AB; 12625 wetmore road; suite 308; san antonio TX 78247
• MDR Report Key: 8925455
• MDR Text Key: 155351058
• Report Number: 8925455
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 08/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1