MAUDE Adverse Event Report: DATASCOPE CORP., DATASCOPE INTRA-AORTIC PUMP; INTRA-AORTIC BALLOON PUMP

Model Number CS300

Device Problems Low Audible Alarm (1016); Component Falling (1105); Moisture Damage (1405); Failure to Power Up (1476)

Patient Problem Death (1802)

Event Date 04/10/2014

Event Type  Death  

Event Description

Customer stated while transporting a pt to the icu, the pt coded.While attempting to resuscitate the pt, a saline bag fell and spilled all over the device.The device stopped working.The customer stated the pt did pass, but was not because of the iabp.The iabp does not power up and emits a steady audible tone.

Manufacturer Narrative

The device history record for the iabp involved in the event was reviewed.There are no nonconformances related to the reported event.Evaluation updates: saline spilled on iabp causing electrical fail #120.Tested iabp for use and it would go into alarm immediately.After troubleshooting the service rep replaced the motor controller board ((b)(4)).The iabp was tested to factory specifications.It functioned normally and was returned to the customer.This type of subject complaint will be monitored and evaluated in monthly basis.(b)(4).

• Brand Name: DATASCOPE INTRA-AORTIC PUMP
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): DATASCOPE CORP.,; 1300 macarthur blvd.; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: tina evancho, mgr ; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 3814912
• MDR Text Key: 4479611
• Report Number: 2249723-2014-00602
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS300
• Device Catalogue Number: 0998-00-3023-XX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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 Outcome(s): Death