MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-55

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 10/22/2021

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) battery failed.The unit alarmed for the reported malfunction.Event occurred as a result of the batteries exceeding its shelf life.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp.The fse determined that the batteries were expired.To fix the issue, the fse replaced the 12v batteries, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

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 24 month product complaint trend data for the period nov 2019 through oct 2021 was reviewed.There were no triggers identified for the review period.There was capa mah tw-209148 identified for the reported failure mode ¿battery malfunction¿ and product ¿cs100¿.The capa is currently in ¿closed - effective" state.

• Brand Name: CS100 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12819451
• MDR Text Key: 280814162
• Report Number: 2249723-2021-02629
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: 10607567107295
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

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: Health Professional
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.