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

Model Number 0998-00-0800

Device Problems No Display/Image (1183); Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)

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

Event Date 09/10/2019

Event Type  malfunction  

Event Description

Intra-aortic balloon pump made a high pitch noise then the screen went black and completely stopped working.It was still powered on, but not working.The rn turned off the machine then turned it back on and it resumed working.Rn called maquet for support.They recommended taking machine out of service and submit a work request, which was done.

• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10133153
• MDR Text Key: 194493562
• Report Number: 10133153
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/26/2020,09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1