MAUDE Adverse Event Report: CAESAREA MEDICAL ELECTRONICS LTD. BODYGUARD 545 PCA INFUSION PUMP; PUMP, INFUSION, PCA

Model Number 545

Device Problems Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)

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

Event Date 01/29/2019

Event Type  malfunction  

Event Description

About 5 minutes prior to observing the device shutdown, the pump emitted an unfamiliar beeping and the green light was blinking.The screen read "near end".The respiratory therapist cleared the error; then, the device shut down shortly after.

• Brand Name: BODYGUARD 545 PCA INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): CAESAREA MEDICAL ELECTRONICS LTD.; cme america; 14998 w 6th ave ste 830; golden CO 80401
• MDR Report Key: 8394010
• MDR Text Key: 137976550
• Report Number: 8394010
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/28/2019,02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 545
• 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: 02/28/2019
• Device Age: 2 YR
• Date Report to Manufacturer: 03/06/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1