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

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

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse checked the system diagnostic found error "electrical test fails code # 53." the fse found moisture present on the shuttle transducer.The fse cleaned all the moisture.The fse performed all the functional test, passed successfully.The fse checked the performance of the unit with the trainer and balloon connected.The unit is not working.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was displaying a failure message.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, e2, e3, g3, g4, g7, h2, h10, h11 corrected fields: a1, b5, b6, b7, d11, h6 (medical device ¿ problem code, component codes).The getinge field service engineer (fse) has confirmed that the iabp unit is now working.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) was displaying a failure message.There was no patient involved and no adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp unit.The fse checked in system diagnostic found error "electrical test fails code # 53".The fse checked unit, found the moisture present on the shuttle transducer.The fse cleaned all the moisture.Checked performance of the unit with trainer and balloon connected, unit working satisfactory.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that before use, the cs100 intra-aortic balloon pump (iabp) was displaying a system failure message.There was no patient involved and no adverse event was reported.

• 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: 13760501
• MDR Text Key: 289467098
• Report Number: 2249723-2022-00515
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2023

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: Other
• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: 03/15/2022; 08/25/2023
• Supplement Dates FDA Received: 04/08/2022; 08/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1