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

Model Number 0998-00-3023-53

Device Problem Failure to Power Up (1476)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/19/2022

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit. The fse observed 0 vdc voltage¿s on the power supply's output. The fse suspects problem with power supply assembly. The fse needs to check with the working one to confirm the same. The repairs are ongoing. A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during a routine check prior to use on a patient, the cs300 intra-aortic balloon pump (iabp) was not powering on both batteries in addition to the alternative current (a/c) mains. There was no patient involvement, and no adverse event was reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13517133
• MDR Text Key: 287030841
• Report Number: 2249723-2022-00273
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/11/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No Answer Provided
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse