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

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit is not required to be reviewed per (b)(4) since the device manufacture date is greater than one year from the event date.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.

Event Description

It was reported that the facility perfusionist was showing another perfusionist how to remove the cardiosave intra-aortic balloon pump (iabp) from the console for transport.The customer stated that the unit would not "click" when replaced into the pump console.However they confirmed that the monitor had the hybrid symbol on the touch screen when the pump was placed in the console.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: 7707980
• MDR Text Key: 114823861
• Report Number: 2249723-2018-01228
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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