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 Problem Power Problem (3010)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge authorized dealer's field service engineer (fse) evaluated the iabp unit and was able to confirm the reported issue.To fix the issue, the fse replaced the power supply and 5000 hours maintenance package.The fse then turned on the iabp and confirmed that the power supply of the iabp was working normally (battery charging and discharging and ac power).Additional information is being requested with regard to the status of the iabp.A supplemental report will be submitted when this information is provided to us.

Event Description

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

Manufacturer Narrative

A getinge service representative reported that the getinge authorized dealer's field service engineer (fse) had performed all functional and safety checks to meet factory specifications.Unit had passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that during a routine check the cs300 intra-aortic balloon pump (iabp) had power supply issues.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Analysis of production: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) the overall 12 month product complaint trend data for the period feb 2020 through jan 2021 was reviewed.There were no triggers identified for the review period.

• 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 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11297065
• MDR Text Key: 230988548
• Report Number: 2249723-2021-00227
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

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: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 10/27/2021; 04/21/2022
• Supplement Dates FDA Received: 11/16/2021; 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1