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 Failure to Zero (1683)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2022

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse observed that the x2 drive pressure transducer was not zeroing out and readings were not within factory specifications.The fse found the leakage in the k7 solenoid.The unit requires a drive manifold assembly for testing purpose to confirm the diagnosis.A supplemental report will be submitted when additional information is provided.The full name of the event site was shortened due to field character limit; the full name is (b)(6).

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) had an inaccurate balloon waveform on the display.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 data: b4, e2,e3,g2,g3,g6,g7,h2,h10,h11 corrected data: b5,b6,b7,d5,d10,h6(clinical & impact ).

Event Description

It was reported that during routine check, the cs100 intra-aortic balloon pump (iabp) had an inaccurate balloon waveform on the display.There was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

Additional information: event site postal code: (b)(6).A getinge field service engineer (fse) checked and observed that x2 drive pressure transducer is not zeroing.Its showing -370 mm hg reading.After checked the machine thoroughly, found leakage in k7 solenoid.Required drive manifold assembly for testing purpose to confirm the diagnosis.Fes replaced manifold drive assembly (0104-00-0018) to resolve the issue and machine is working fine.

• 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: 13663696
• MDR Text Key: 288613444
• Report Number: 2249723-2022-00442
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• 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
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1