MAUDE Adverse Event Report: ARJOHUNTLEIGH INC FLOWTRON PNEUMATIC COMPRESSION PUMP; SLEEVE, LIMB, COMPRESSIBLE

Model Number ACS 800

Device Problems Break (1069); Failure to Charge (1085); Disconnection (1171); Connection Problem (2900)

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

Event Date 09/01/2015

Event Type  malfunction  

Event Description

We have experienced repeated failures with two areas of the acs 800.The patient leads exit the main body of the pump directly perpendicular to the main housing.These leads are very stiff and exposed in the way they are positioned.The tubing then is very often broken from its housing and connection to the pump.The second area of attention was the attachment of the power cord to the main body of the pump.This has a plastic panel that screws on to pinch the power cord and hold it in place.This cord would often get pulled out from the unit, preventing the unit from charging.Neither of these cords protruding from the unit has a storage solution.They are usually coiled and rubber-banded during storage.This makes it very easy to handle the unit inappropriately and could contribute to the excessive breaking of these pieces.

• Brand Name: FLOWTRON PNEUMATIC COMPRESSION PUMP
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): ARJOHUNTLEIGH INC; 12625 wetmore rd ste 308; san antonio TX 78247
• MDR Report Key: 5112574
• MDR Text Key: 27175294
• Report Number: 5112574
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: ACS 800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1