MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-55

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2022

Event Type  malfunction  

Manufacturer Narrative

Type of investigation not yet determined: a supplemental report will be submitted upon receipt of additional information.

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) was displaying electrical test failure code # 50.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Manufacturer Narrative

Updated fields: b4, d9(device available for eval), g3, g6, g7, h2, h3, h4, h6(investigation type, investigation findings, component codes & investigation conclusions), h10 a getinge field service engineer (fse) was dispatched to investigate the issue.In order to fix the issue, the fse reconnected the motor control board after cleaning it.Then, the fse checked the unit and found it working properly after all test.The unit was then handed over to the customer in good working condition.

Event Description

N/a.

Event Description

It was reported that during routine check, the cs100 intra-aortic balloon pump (iabp) was displaying electrical test failure code # 50.There was no patient involvement.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13722726
• MDR Text Key: 286947849
• Report Number: 2249723-2022-00497
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: 10607567107295
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2023

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: Health Professional
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 06/06/2023; 07/17/2023
• Supplement Dates FDA Received: 06/15/2023; 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1