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

Model Number	0998-00-3013-92
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing of actual/suspected device : a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and found the battery test failed < 137 min of autonomy.The fse resolved the issue by replacing the batteries.The fse performed functional and safety checks to meet 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.The initial reporter named in is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).
Event or Problem Description
It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cs100 intra-aortic balloon pump (iabp) failed battery test requiring battery replacement.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Analysis of production: (3331) the device history record 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) 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) the overall 24 month product complaint trend data for the period (b)(6) 2019 through (b)(6) 2021 was reviewed.There were no triggers identified for the review period.

• Brand Name: CS100 UTS INTRA-AORTIC BALLOON PUMP FRENCH 110V
• Common Device Name: 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: 12638307
• Report Number: 2249723-2021-02363
• Device Sequence Number: 5541064
• Product Code: DSP
• UDI-Device Identifier: 10607567108131
• UDI-Public: 10607567108131
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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
• Operator of Device: Other
• Device Model Number: 0998-00-3013-92
• Device Catalogue Number: 0998-00-3013-92
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown