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

Model Number N/A

Device Problems Fitting Problem (2183); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint.A supplemental report will be submitted when subsequent information is provided.

Event Description

It was reported that a patient was fitted with a sensation balloon catheter during operation.At this time, the arterial trace and pressure value could not be read on the cs300 intra-aortic balloon pump (iabp).The iabp had displayed a iab optical sensor failure message.The iabp was operated by connecting the ecg to the patient.Approximately 5 hours later, the iabp was able to read the numerical value of the pressure before the arterial trace.From time to time the customer has encountered this situation.No adverse event was 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: 7619290
• MDR Text Key: 112183243
• Report Number: 2249723-2018-01039
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• 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: 0998-00-3023-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: No
• 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