MAUDE Adverse Event Report: ARROW INTERNATIONAL INC AUTOCAT2; INTRA AORTIC BALLOON PUMP

Device Problems No Audible Alarm (1019); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 04/24/2016

Event Type  malfunction  

Event Description

Noticed that the screen reads "on battery" with no associated audible alarm.Traced the electric plug and it was connected to a red outlet.Confirmed the plug was securely placed into console.On the back of the console, where the plug goes into, it had the green "power indicator" bulb on as well as the yellow "battery charged" bulb on.

• Brand Name: AUTOCAT2
• Type of Device: INTRA AORTIC BALLOON PUMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC; 16 elizabeth dr.; chelmsford MA 01824
• MDR Report Key: 5649739
• MDR Text Key: 45034520
• Report Number: 5649739
• Device Sequence Number: 1
• Product Code: DSP
• 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: Other
• Type of Report: Initial
• Report Date: 04/29/2016

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1