MAUDE Adverse Event Report: COMPRESSION THERAPY CONCEPTS (CTC) VASOPRESS SUPREME MINI; SEQUENTIAL COMPRESSION DEVICE

Model Number VP500DM

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 02/09/2015

Event Type  malfunction  

Event Description

(b)(6) started to use the sequential compression device produced by compression therapy concepts (ctc) in 2013.We started to notice a high failure rate almost immediately.This was reported to the company and they did come in to speak with us.This group included reps from biomedical engineering, nursing, quality and purchasing.The company did change our entre fleet of pumps after the meeting.The high failure rate continues with (b)(4).Failures are most often related to the cp/op alarm.This requires us to send the pump out to the company for repair.

• Brand Name: VASOPRESS SUPREME MINI
• Type of Device: SEQUENTIAL COMPRESSION DEVICE
• Manufacturer (Section D): COMPRESSION THERAPY CONCEPTS (CTC); eatontown NJ
• MDR Report Key: 4728327
• MDR Text Key: 5667208
• Report Number: MW5042257
• Device Sequence Number: 1
• Product Code: JOW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VP500DM
• Device Catalogue Number: VP500DM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other