MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC.; SLEEVE, LIMB, COMPRESSIBLE

Device Problems Disconnection (1171); Device Operates Differently Than Expected (2913)

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

Event Date 10/12/2015

Event Type  malfunction  

Event Description

When the device was to be used it failed to work properly.The pressure device lines had been disconnected to the internal workings of the machine.The repair requires unit to be returned to manufacturer.

• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 12625 wetmore road; san antonio TX 78247
• MDR Report Key: 5253940
• MDR Text Key: 32268403
• Report Number: 5253940
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/22/2015,11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Unknown
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2015
• 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
• Treatment: UNKNOWN.