MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-53

Device Problems Electrical /Electronic Property Problem (1198); Appropriate Term/Code Not Available (3191)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

The full name of the event site in was shortened due to field character limit; the full name is dr.(b)(6).Testing of actual/suspected device : a getinge field service engineer (fse) was dispatched to evaluate the iabp and observed offset value for atmospheric trans - (-70 )and x1 =( -34).To fix the issue, the fse cleaned and reconnected the pressure transducer, and restarted system with no problem found.Unit checked for more than 1 hour with trainer balloon and worked fine.Again, rechecked offset value atmospheric trans= (1) and x1 = (1) and suspected the maintenance system¿s front end board and 1 pressure transducer.A supplemental report will be submitted if this information is provided to us.

Event Description

It was reported that during routine check, the cs100 intra-aortic balloon pump (iabp) gave maintenance code - 1 and electrical test fail # 52 & 54 message.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Additional information: event site postal code: (b)(6).Additional contact information: (b)(6).A getinge field service engineer (fse) evaluated the unit, but was unable to reproduce the reported malfunction.The fse kept the unit under observation.No problem was found.The fse performed all safety checks and tests.The iabp was handed over to the customer in good, working condition.

Event Description

N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• 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: 12475932
• MDR Text Key: 271521915
• Report Number: 2249723-2021-02090
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: 10607567107394
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 02/24/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2006
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1