MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0998-00-3023-53

Device Problems Failure to Sense (1559); Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.The service territory manager (stm) tested the fiber optic module and it passed to specifications.The stm could not duplicate the alleged malfunction.However, the fault logs show "no trigger" and "no pressure trigger" alarms occurred on the reported event date.The iabp passed all functional and safety tests per factory specifications, returned to the customer and cleared for clinical use.

Event Description

The customer stated that the cs300 intra aortic balloon pump (iabp) is not sensing / calibrating ap cable.The circumstances under which the event occurred were not reported however no patient involvement or adverse event were reported.

• Brand Name: CS300
• 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: 6835050
• MDR Text Key: 84646817
• Report Number: 2249723-2017-00411
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2017

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: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2004
• 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