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

Model Number CS300

Device Problems Loss of Power (1475); Failure to Reset (1532)

Patient Problem No Information (3190)

Event Date 05/06/2019

Event Type  Injury  

Event Description

Balloon pump began alarming low vacuum then suddenly changed to system failure and shut down. Machine unable to be restarted. Treatment had to be terminated as unable to correct machine issue. 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 / DATASCOPE CORP.
• MDR Report Key: 8604818
• MDR Text Key: 145023542
• Report Number: MW5086576
• 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

• Type of Report: Initial
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CS300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 05/10/2019 Patient Sequence Number: 1