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

Catalog Number 0998-00-0800-31

Device Problems No Audible Alarm (1019); No Display/Image (1183); Loss of Power (1475); Device Displays Incorrect Message (2591)

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

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

The following is a correction to the narrative previously reported below: a getinge service representative inspected the iabp device and found that the even though the mains power plugged-in status was showing on the screen, but the batteries were not charging.After removing the console from the cart and re-engaging to the cart, the batteries started charging.The service rep checked the error logs and the power activity log but couldn't find any iabp shutdown related errors or any other alarms related to low battery or battery not detected.A company representative from the business unit reported that the iabp unit is back in clinical use.The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service representative inspected the iabp device and found that the even though the mains power plugged-in status was showing on the screen, but the batteries were not charging.After removing the console from the cart and re-engaging to the cart, the batteries started charging.The service rep checked the error logs and the power activity log but couldn't find any iabp shutdown related errors or any other alarms related to low battery or battery not detected.A company representative from the business unit reported that the iabp unit is back in clinical use.No information has been provided as to whether parts were replaced.

Event Description

It was reported that the intra-aortic balloon pump (iabp) was running for 1 hour in icu post transfer of patient from cardiac cath lab.When in the icu, it was noted that the screen went blank and the device turned off.There was no audible alarm prior to this.Power was plugged in and batteries were reportedly charged.The iabp was initially turned on again but the error occurred a second time.The cardiosave iabp was urgently replaced with a second unit and therapy recommenced.No adverse event was reported.This device has been quarantined to be investigated by getinge bme staff to determine cause of error.The customer later reported to a company representative that at the time of the event, the iabp emitted "battery not detected " alarm.

• 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: 6886854
• MDR Text Key: 88168744
• Report Number: 2249723-2017-00519
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-31
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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
• Patient Age: 80 YR