MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-45

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 04/23/2021

Event Type  malfunction  

Event Description

It was reported that a system failure occurred, during use on a patient, in the cs100 intra-aortic balloon pump (iabp).There was no report of patient harm, serious injury or adverse event.

Manufacturer Narrative

Testing of actual/suspected device: a getinge authorized distributor field service engineer (fse) was dispatched to evaluate this unit and was able to confirm the reported event in the device logs but was not able to reproduce the reported issue.The fse performed a cleaning and drying of the main board.The unit passed all functional and safety tests per factory specifications.The iabp was released to the customer and cleared for clinical service.Upon completion of our investigation, a supplemental report will be submitted.The full name of the event site was shortened due to field character limit; the full name is: (b)(6).

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h4, h6, h10.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 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: 12894379
• MDR Text Key: 281417713
• Report Number: 2249723-2021-02752
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107790
• UDI-Public: 10607567107790
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-45
• Device Catalogue Number: 0998-00-3013-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN.