MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/10/2021

Event Type  Death  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) displayed "power up test code #4 fails¿ message. The next pump started and provided therapy for less than a minute. During that time, a restriction alarm occurred and pumping was resumed via the ¿start¿ key. The pump then alarmed with an ¿internal communication failure¿ message. The iab was inserted emergently in the emergency department to a critically ill patient. At startup of these pumps, the critical patient was also being given chest compressions by a mechanical cpr device. The patient did not survive. The physician has verbalized that the "malfunction of the iabp did not change the patient outcome". The customer did not wish to participate in giving iab or patient information for this event. This reported is for the iab with no reported malfunction. Two separate reports will be submitted for the 2 involved cardiosave intra-aortic balloon pumps(iabps).

Manufacturer Narrative

The device will not be returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. Complaint record id # (b)(4).

• Brand Name: UNKNOWN INTRA-AORTIC BALLOON
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 13130401
• MDR Text Key: 283077450
• Report Number: 2248146-2021-00896
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes

Type of Device Usage

Patient Treatment Data

Date Received: 12/31/2021 Patient Sequence Number: 1

Treatment

CARDIOSAVE / (B)(4).CARDIOSAVE / (B)(4).