MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Term/Code Not Available (3191)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

Type of investigation not yet determined (4118 / 3233): a supplemental report will be submitted upon receipt of additional information.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) was displaying the failure of the air test.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) was displaying the failure of the air test.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Manufacturer Narrative

A supplemental report will be submitted upon receipt of additional information.

Manufacturer Narrative

Device not accessible for testing (4117 / 3233): at this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event.Communication/interviews (4111 / 3233): a getinge field service engineer (fse) reported that the customer figured out they were using the wrong luer plug during the safety disk leak test.There were no issues observed when using the correct luer plug, so no service was needed.A supplemental report will be submitted upon completion of our investigation.H3 other text : not returned to manufacturer.

Event Description

It was reported that during the weekly safety disk leak test performed by the customer, the cs300 intra-aortic balloon pump (iabp) was displaying the failure of the air test.There was no patient involved and no adverse event was reported.

Event Description

N/a.

• Brand Name: CS300 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: 13501704
• MDR Text Key: 286082353
• Report Number: 2249723-2022-00258
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1