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 Unexpected Shutdown (4019)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device (10/213): a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and while reviewing the fault logs was able to verify fault codes 58 & 124.The fse loaded new b17 software and performed pneumatic checks.Unit passed all tests.Calibration, safety, and functionality checks passed factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that before use on a patient, the cardiosave intra-aortic balloon pump (iabp) kept cutting off; unit shut off twice.There was no patient involved and no adverse event was reported.

Manufacturer Narrative

Corrected fields: h6 (health effect ¿ impact code).

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11 corrected field: h6 (health effect ¿ impact codes) 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 sep 2019 through aug 2021 was reviewed.There were no triggers identified for the review period.

Event Description

N/a.

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12416820
• MDR Text Key: 271947516
• Report Number: 2249723-2021-01996
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2022

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 09/02/2021; 01/20/2022
• Supplement Dates FDA Received: 09/30/2021; 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1