MAUDE Adverse Event Report: MAPQUET MAPQUET; IABP

Model Number 068400057801U

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/26/2016

Event Type  Injury  

Event Description

Iabp alarm reading blood in line.Machine would not run, unable to clear.No blood observed in line.Balloon had to be removed, pt taken off pump.

• Brand Name: MAPQUET
• Type of Device: IABP
• Manufacturer (Section D): MAPQUET
• MDR Report Key: 5839910
• MDR Text Key: 51032267
• Report Number: MW5063770
• Device Sequence Number: 1
• Product Code: DSP
• 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: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2019
• Device Model Number: 068400057801U
• Device Lot Number: 3000032140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 81