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

Model Number N/A

Device Problem Charging Problem (2892)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted when this information is provided to us.

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) would not indicate the battery charging.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

Updated fields: a1, a3 (to be left blank), b4, b5, d9, e2, e3, g2, g3, g6, h2, h3, h6, h10, h11.Corrected field: e1(event site telephone).A getinge field service engineer (fse) evaluated the iabp unit and reported that the iabp was not getting charged.Repairs have not yet taken place.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted when this information is provided to us.

Event Description

It was reported that during a routine check performed by the customer, the cs100 intra-aortic balloon pump (iabp) would not indicate the battery charging.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during a routine check by the customer, the cs100 intra-aortic balloon pump (iabp) would not indicate the battery charging.The unit alarmed for the reported malfunction.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The fse determined that the power supply was defective and replaced it, 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.

Manufacturer Narrative

Analysis of production: (3331/213) 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: (4109/213) 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 mar 2019 through feb 2021 was reviewed.There were no triggers identified for the review period.

Event Description

N/a.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11381711
• MDR Text Key: 233748440
• Report Number: 2249723-2021-00427
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: 10607567107295
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3013-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1