MAUDE Adverse Event Report: MAQUET/GETINGE / /DATASCOPE CORP INTRA-AORTIC BALLOON PUMP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0568-01U

Device Problem Material Rupture (1546)

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

Event Date 06/01/2020

Event Type  Injury  

Event Description

Intra-aortic balloon pump rupture.Fda safety report id# (b)(4).

• Brand Name: INTRA-AORTIC BALLOON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): MAQUET/GETINGE / /DATASCOPE CORP ; wayne NJ 07470
• MDR Report Key: 10128198
• MDR Text Key: 194472416
• Report Number: MW5094864
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0568-01U
• Was Device Available for Evaluation?: Yes
• 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): Life Threatening
• Patient Age: 40 YR
• Patient Weight: 60