MAUDE Adverse Event Report: DATASCOPE CORP / MAQUET CARDIOVASCULAR LLC IABP MAQUET; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 2277

Device Problem Inflation Problem (1310)

Patient Problems Hypoxia (1918); No Code Available (3191)

Event Date 04/18/2019

Event Type  malfunction  

Event Description

Very ill pt.Cad, acute hypoxic resp failure.Pt to cath lab for heart cath and iabp placement, cath completed.Pt had bradycardiac arrest.Tried to inflate iabp balloon with multiple inflations without success.Second pump immediately available and placed with success.Fda safety report id# (b)(4).

• Brand Name: IABP MAQUET
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP / MAQUET CARDIOVASCULAR LLC
• MDR Report Key: 8587282
• MDR Text Key: 144441098
• Report Number: MW5086424
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2277
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR