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

Catalog Number UNKNOWN

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/26/2020

Event Type  Injury  

Manufacturer Narrative

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. (b)(4).

Event Description

It was reported during cardiosave intra-aortic balloon pump(iabp) therapy, the device spontaneously failed while in operation on a critical care patient. The intra-aorta balloon pump (iabp) suddenly shutdown. This spontaneous fail is a duplicate of an occurrence during the preventive maintenance battery test on a full battery 5 weeks ago. After the preventive maintenance incident, the customer spoke with getinge tech support and completed 2 subsequent 60 minute discharge tests on the battery with no errors, per their instructions. As all other tests passed during the preventive maintenance (pm), this occurred only during the battery test at the end of the pm function, calibration and operation tests. Per the nurse the unit was plugged in at the time of failure. This battery was fully charged both times and failed with 25 to 35 minutes of use. Patient lost blood pressure with significant desaturation. There was no reported malfunction on the intra-aortic balloon(iab).

• 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
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: dorota wolpiuk ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 9979053
• MDR Text Key: 188530708
• Report Number: 2248146-2020-00233
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• 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 Answer Provided
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 04/20/2020 Patient Sequence Number: 1