MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Power Problem (3010)

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

Event Date 02/21/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted when this information is provided to us.

Event Description

It was reported that prior to use on a patient, the cardiosave intra-aortic balloon pump (iabp) had to be turned on 4 times before working.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp.Upon start up, after self-test, the two screens turned black and then hissing.Upon the second boot, the console worked correctly.The fse also observed error 118 concerning the twisted cable, a problem of communication between the graphics card and the execution card and put lubricant on the electrical contact.To fix the issue, the fse replaced the coiled cable and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that prior to use on a patient, the cardiosave intra-aortic balloon pump (iabp) had to be turned on 4 times before working.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Analysis of production: (3331) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr 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 serial number and reported failure mode.Trend analysis: (4110) the overall 24 month product complaint trend data for the period (mar 2019 through feb 2021) was reviewed.There were no triggers identified for the review period.

• Brand Name: CARDIOSAVE HYBRID TYPE E/F PLG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• MDR Report Key: 11517045
• MDR Text Key: 240967273
• Report Number: 2249723-2021-00551
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/27/2021
• Patient Sequence Number: 1