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 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: the getinge field service engineer reported that replaced the power management pcb (new products), and retrieve the spare parts.After replacement, the function test was normal, the ac/dc conversion was normal, the battery can be charged and discharged normally, replace a new battery, and after replacement, the old product was retrieved as well, the battery function test was normal.Unit passed all functional and safety test per factory specifications.The iabp was released to the customer and cleared for clinical service.Upon completion of our investigation, a supplemental report will be submitted.

Event Description

It was reported by the distributor that before use, the batteries in the cardiosave intra-aortic balloon pump (iabp) will not charge.There was no patient involvement, and there was no adverse event reported.

Manufacturer Narrative

Analysis of production: (3331) 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) 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) the overall 24 month product complaint trend data for the period aug 2019 through jul 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: 12268132
• MDR Text Key: 264783631
• Report Number: 2249723-2021-01691
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 10/29/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1