MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-55

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the unit and found that the back up battery was too low.The fse determined that the batteries needed replacement.The fse submitted an estimate to the customer and awaits approval.Notwithstanding, the fse performed all functional and safety checks to meet factory specifications were performed.The iabp was then released to the customer and cleared for clinical service.At this time, additional information is being requested with regard to the repair and status of the iabp unit.A supplemental report will be submitted when this information is provided to us.(b)(6).

Event Description

It was reported that while servicing a unit, the getinge field service engineer (fse) found that the cs300 intra-aortic balloon pump (iabp) backup battery was low.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h6 (investigation findings, component codes, health effect - impact codes, investigation conclusions), h10.The getinge field service engineer (fse) has advised that the customer has not approved the replacement of the batteries.It was noted that the customer is currently using the iabp unit on mains power only and not on the batteries.If additional information is provided, a supplemental report will be submitted.

Event Description

It was reported that while servicing a unit, the getinge field service engineer (fse) found that the cs300 intra-aortic balloon pump (iabp) backup battery was low.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Historical data analysis: (4109/131) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110/131) 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.Analysis of production: (3331/131) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported 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.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11379829
• MDR Text Key: 234222821
• Report Number: 2249723-2021-00412
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2021

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: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1