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

Model Number 0998-00-0800-XX

Device Problems Air Leak (1008); Device Alarm System (1012); Loss of Power (1475)

Patient Problem Death (1802)

Event Date 07/08/2016

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for the iabp involved in the event was reviewed.There were no non-conformances in the dhr related to the reported event.The iabp is currently under investigation by the company representative but the evaluation results are not available yet.

Event Description

The customer reported that immediately after therapy started some sounds were heard, and the pump was losing air.Twice, the iabp stopped working for 30 seconds, but no alarm was generated.Therapy resumed for 6 hours on the same iabp with no adverse event reported.This occurred in the evening, but the patient passed away the following morning.There is no device relationship directly with the patient death.As per hospital policy, no patient information is provided.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 5861405
• MDR Text Key: 51688576
• Report Number: 2249723-2016-00024
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-XX
• Device Catalogue Number: 0998-00-0800-XX
• Other Device ID Number: CA233537H3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death