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

Catalog Number UNKNOWN

Device Problems Device Alarm System (1012); Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete the evaluation.If provided, we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the balloon ruptured and the cs300 intra-aortic balloon pump (iabp) did not emit an alarm.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the balloon ruptured and the cs300 intra-aortic balloon pump (iabp) did not emit an alarm.There was no reported injury to the patient.

Manufacturer Narrative

Correction to evaluation method codes: from [4109 historical data analysis] to [blank].The device has not been 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 # (b)(4), record id # (b)(4).

• Brand Name: UNKNOWN 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: 8464315
• MDR Text Key: 140512893
• Report Number: 2248146-2019-00250
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1