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 Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to the customer's site.The fse evaluated the iabp and duplicated batteries in slot two hard to remove.The stm cleaned battery compartment replaced conical springs but problem persists.The iabp unit taken out of service to be repaired at factory service depot.Additional information has been requested, and we will report accordingly if it becomes available.(b)(6).

Event Description

It was reported that during a routine check the cardiosave intra-aortic balloon pump (iabp) had a battery stuck in the life evac unit.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6, h10.The iabp was received at the factory service depot.The getinge service territory manager (stm) at the service depot replaced the console chassis and associated parts to correct the reported issue.A preventive maintenance was completed with full functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.A supplemental report will be submitted if any additional pertinent information is received.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

A getinge service territory manager (stm) reported that the iabp unit was cleared for clinical use and returned to customer.A supplemental report will be submitted when our investigation is completed.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: h4.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 there was one similar complaint reported for the reported failure mode and the reported serial number.Trend analysis: (4110) the overall 12 month product complaint trend data for the period jan-2020 through dec-2020 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 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11152080
• MDR Text Key: 226273433
• Report Number: 2249723-2021-00046
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 06/02/2021; 08/03/2021; 01/24/2022
• Supplement Dates FDA Received: 06/25/2021; 08/27/2021; 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.