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

Model Number 0998-00-3023-53

Device Problems Failure to Charge (1085); Off-Label Use (1494); Battery Problem (2885)

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

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to investigate and reported that batteries lasted only 65 min.The problem was solved by replacing the batteries 0146-00-0039 battery, sealed lead acid,12v.The stm then performed full functional and safety tests.All tests passed per manufacture specifications.The iabp was returned to the customer and cleared for clinical use.

Event Description

It was reported that while walking the patient, a low battery alarm was activated.The customer plugged the cs300 intra-aortic balloon pump (iabp) into wall power and swapped to another pump.The customer informed that batteries were charged over night and ran 10 minutes.There was no harm or injury to the patient and no adverse event was reported.

Event Description

It was reported that during off-label use, while walking the patient, a low battery alarm was activated.The end user plugged the cs300 intra-aortic balloon pump (iabp) into wall power and swapped to another iabp unit.The customer reported that the batteries were charged overnight and ran for 10 minutes.There was no harm or injury to the patient and no adverse event was 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
• MDR Report Key: 11574574
• MDR Text Key: 242466159
• Report Number: 2249723-2021-00634
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/29/2021
• Patient Sequence Number: 1
• Treatment: ASKU (ASKED BUT UNKNOWN)