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

Catalog Number 0998-00-0800-53

Device Problems Failure to Power Up (1476); Charging Problem (2892)

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

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

The service call was handled over the phone between a getinge field service engineer and the facility's biomed engineer 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.The getinge field service engineer (fse) contacted the customer via telephone.The customer stated that the batteries were fully depleted and the unit is not charging the batteries.The fse instructed the biomed to remove the console and reinsert the cardiosave console into cart.The biomed stated that the batteries began to charge.The fse then instructed the biomed to charge the batteries overnight and he will follow up on battery charging issue.The fse later followed up and the biomed stated that the batteries were fully charged and the issue was corrected.It was concluded that the batteries were not charging due to the cardiosave console not being installed correctly into cart.This caused the batteries not to charge and not operate in ac operation.The failure was corrected and the cardiosave was put back into clinical operation.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) would not turn on and the batteries would not charge.This event occurred during a service/test by the customer.There was no patient involvement, thus 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: 7149227
• MDR Text Key: 96015680
• Report Number: 2249723-2017-01079
• 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
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2015
• 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