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

Device Problems Disconnection (1171); Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

Pcea pump was not working properly when we tried to use it for pain management.Machine indicated outside power is disconnected even when it is plugged in.This delayed administration of medication and required additional iv pain medications.

• Brand Name: CURLIN MEDICAL PCEA PUMP
• Type of Device: INFUSION PUMP, PCEA
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 10805 rancho bernardo rd; san diego CA 92127
• MDR Report Key: 4209038
• MDR Text Key: 21450131
• Report Number: 4209038
• Device Sequence Number: 1
• Product Code: MEA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• 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: 10/13/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2014
• Patient Sequence Number: 1
• Patient Age: 60 YR