MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP CURLIN PAINSMART; PUMP, INFUSION

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 12/05/2014

Event Type  malfunction  

Event Description

Patient on pca dilaudid.Pca pumps kept beeping that there was an error with 3a.Pca pumps replaced 3 times and each alarmed with the same error.Turning pump off and restarting did not solve the problem.

• Brand Name: CURLIN PAINSMART
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 10805 rancho bernardo rd; san diego CA 92127
• MDR Report Key: 4506707
• MDR Text Key: 5404798
• Report Number: 4506707
• Device Sequence Number: 1
• Product Code: LZH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/05/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR