MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problem Failure to Charge (1085)

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit and was able to confirmed batteries not charging.No charging voltage was present.The fse placed order for repair parts.When the fse returned to the site on 6/29/2021, the batteries (0146-00-0097) , the power supply assy (0997-00-1180) and power supply monitor board (0670-00-1166 ) were replaced.This corrected the issue.The fse stated that batteries were weak and completely depleted.Device passed all functional and safety tests according to factory specifications.The iabp was returned to customer and cleared for clinical use.Upon completion of our investigation, a supplemental report will be submitted.

Event Description

It was reported that during routine check, the battery in the cardiosave intra-aortic balloon pump (iabp) was dead.There was no patient involvement, and no adverse event 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 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 jul 2019 through jun 2021 was reviewed.There were no triggers identified for the review period.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• MDR Report Key: 12182285
• MDR Text Key: 261995412
• Report Number: 2249723-2021-01553
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/20/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1