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 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

The full name of the event site in initial reporter was shortened due to field character limit; the full name is (b)(6).The full name of the event site address in initial reporter was shortened due to field character limit; the full name is (b)(6).Testing of actual/suspected device : a getinge field service engineer (fse) was dispatched to evaluate the iabp.The fse was able to verify the alarms in the iabp¿s diagnostic error log.The main board and datasettes were removed from the iabp unit and installed in another iabp unit.The fse determined that the main board was the fault origin.The main board and datasettes were then returned to the defective device.Unrelated to the reported issue, it was also observed that the safety disk change time of the device had passed.Due to the software version change, the fses recommended to supply the main board together with the data sets.The device has not been repaired at this time and remains in a faulty state.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) gave electrical test fail code 35 alert.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.

Manufacturer Narrative

The customer was presented with a cost estimate for repairs; however, no response has been received at this time.The iabp unit remains faulty.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during a routine check, the cardiosave intra-aortic balloon pump (iabp) generated an electrical test fail code #35 alert.There was no patient involvement, and no adverse event reported.

Event Description

N/a.

• 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: 13060311
• MDR Text Key: 282618041
• Report Number: 2249723-2021-02935
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• UDI-Public: 10607567112541
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1