MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-58

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted when this information is provided to us.

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) had electrical test failure.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) had electrical test failure.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp and located the fault.The fse replaced the safety disk assembly and the motor controller pcb.The fse verified the correct operation of the equipment.

Manufacturer Narrative

Updated fields: b4, d4(version or model #), g3, g6, h2, h4, h6, h10, h11.Corrected fields: h10.The date received by mfg(g3) in the initial mdr was incorrect.The correct date received by mfg for the initial mdr is (b)(6)2021.

Event Description

N/a.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11329000
• MDR Text Key: 232336926
• Report Number: 2249723-2021-00277
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107622
• UDI-Public: 10607567107622
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-3013-58
• Device Catalogue Number: 0998-00-3013-58
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 04/30/2021; 05/27/2021
• Supplement Dates FDA Received: 05/25/2021; 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1