MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-55

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information is being requested in regards to whether or not the customer has requested for getting to service the iabp unit involved.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had a loose piece.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Event Description

It was reported during preventive maintenance (pm) performed by a getinge service territory manager (stm) the cs300 intra-aortic balloon pump (iabp) had a loose piece.There was no patient involved.

Manufacturer Narrative

Updated sections: b4, e2, e3, g3, g6, h2, h10, h11.Corrected sections: b5, b6, b7, d5, d10, e1(name&email), g2(company rep only), h6(health impact).

Manufacturer Narrative

Additional information: event site postal code: (b)(6) a getinge field service engineer (fse) confirmed there was no equipment failure.As a partof pm he replaced the safety disk (0997-00-0985-05).The fse checked the unit and performed functional tests.The unit was returned to the customer and cleared for clinical use.

• Brand Name: CS300 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: 12820476
• MDR Text Key: 284540345
• Report Number: 2249723-2021-02635
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• UDI-Public: 10607567112541
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K063525
• 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: 03/04/2024

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: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 11/11/2022; 02/29/2024
• Supplement Dates FDA Received: 11/22/2022; 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1