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

Model Number 0998-00-3013-65

Device Problems Device Displays Incorrect Message (2591); Appropriate Term/Code Not Available (3191)

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during patient use the cs100 intra-aortic balloon pump (iabp) had a system error.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Updated fields: b4, e1(event site address, city & telephone), g2, g3, g6, g7, h2, h4, h6(investigation type, investigation findings, component codes & investigation conclusions), h10, h11.Corrected fields: b5, g1(contact person).A getinge field service engineer (fse) was dispatched to investigate the issue.The fse was able to replicate the reported issue and was able to find error code #65 recorded in the fault logs where the opening of the solenoid drive on pressure side failed.So, in order to fix the issue, the fse replaced the manifold drive (0104-00-0018).After the repair of the unit was done, the fse replaced other parts as part of the annual preventive maintenance.The unit passed all functional and safety checks to factory specifications.The unit was then returned to the customer and cleared for clinical use.

Event Description

It was reported that during patient use the cs100 intra-aortic balloon pump (iabp) had a system error.No patient harm was reported.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 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: 12512229
• MDR Text Key: 272669104
• Report Number: 2249723-2021-02144
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: 10607567107684
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-65
• Device Catalogue Number: 0998-00-3013-65
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1