MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Device Displays Incorrect Message (2591); Computer Operating System Problem (2898)

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

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A supplemental report will be submitted when additional information is made available.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) will not boot up, the arrow continuously spins until "system failure alarm" sounds.This event occurred during a routine daily check performed by the customer.There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

A getinge service territory manager (stm) evaluated the iabp and found defective display coiled cable.To resolve the issue, the stm replaced the coiled cable and verified proper boot up function.The stm also found that the helium tank was empty, the console cover was damaged and was pushing against the 300 psi check valve causing it to crack the valve.To resolve these issues, the stm replaced the 300 psi check valve and the console cover.In addition, the stm observed that the critical alarm battery was not functioning and also replaced the critical alarm battery.All functional and electrical safety test were performed and the iabp passed all tests and was cleared for clinical use.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) will not boot up, the arrow continuously spins until "system failure alarm" sounds.This event occurred during a routine daily check performed by the customer.There was no patient involvement and no adverse event was reported.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7525397
• MDR Text Key: 108908662
• Report Number: 2249723-2018-00847
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• 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,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1