MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0479-07

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/11/2021

Event Type  Death  

Manufacturer Narrative

(b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint # (b)(4).

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) was not functioning.Customer has complaint stating that intermittently ecg signal was missing.Engineer has reached on site within 30 minutes and observed that unit was connected to patient and was working properly , after discussion had with user , he came to know that there was some loose contact of ecg lead wire at patient side which was reconnected by user and after that problem was resolved.However next day on (b)(6) 2021 when unit was free from patient , the fse has visited again to hospital to recheck the unit and to ensure functionality of machine.The fse has checked it thoroughly , performed all functional tests and could not observed any problem with unit.During the service visit, the customer notified that the patient death had occurred on (b)(6) 2020.Patients death was due to ischemic heart disease.There was no reported malfunction on the iab.A separate report will be submitted for the cs100 intra-aortic balloon pump(iabp).

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the 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 was performed.Trend analysis (4110/213) - the overall complaint trend data for the period on (b)(6) was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint#: (b)(4).H3 other text: device not returned.

Event Description

N/a.

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 11266540
• MDR Text Key: 229857719
• Report Number: 2248146-2021-00061
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109695
• UDI-Public: 10607567109695
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0684-00-0479-07
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CS100 SA150566L8.; CS100 SA150566L8
• Patient Outcome(s): Death