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

Model Number 0998-00-3023-53

Device Problem Failure to Charge (1085)

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

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and was able to confirm the reported issue.The fse ensured proper charging current when the iabp unit was plugged into ac power.The fse replaced the batteries then performed a battery run test as well as functional tests.Subsequently, the fse completed preventative maintenance (pm) and replaced the safety disk as it has reached its usage hours.All safety, functionality, and calibration checks were performed and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.The full name of the event site was shortened due to field character limit; the full name is: (b)(6) medical center.

Event Description

It was reported that before use, the battery for the cs300 intra-aortic balloon pump (iabp) was not charging and had a poor battery run time.There was no patient involved and no adverse event was reported.

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 there was one similar complaint reported for the reported failure mode and serial number.The historical data was analyzed and escalation was not required for the reported failure mode and serial number.Trend analysis: (4110/213) 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.

Event Description

N/a.

• 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: 11904617
• MDR Text Key: 263597433
• Report Number: 2249723-2021-01152
• 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: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 07/28/2021
• Patient Sequence Number: 1