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

Model Number CS100

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  Injury  

Event Description

Datascope ¿iabpb¿ inserted in cardiac cath lab- pt transferred to icu patient was to be transferred to another facility.When datascope was unplugged the low battery light came on and the screen showed ¿system failure¿.The datascope machine had been plugged into the red outlet (emergency outlet) in icu.All tubing remained intact there no wavelength on the screen a new machine was no wavelength on the screen a new machine was obtained-no patient harm.

• Brand Name: DATASCOPE BALLOON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9540848
• MDR Text Key: 173953982
• Report Number: MW5092009
• 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: 12/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS100
• Device Catalogue Number: (01) 10607567107417
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• 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: 63 YR
• Patient Weight: 91