MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-55

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.Telephone number : (b)(6).

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) unit had a power up failure.

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) unit had a power up failure.No patient involved - routine hospital check.

Manufacturer Narrative

Corrected fields: b5, d5, e1(event site name: (b)(6) hospital , event site address: (b)(6), event site city: (b)(6)).Additional information: e1(event site postal code: (b)(6), event site email: (b)(6)).It was reported that during a routine check the cs300 intra-aortic balloon pump (iabp) was not switching on the first time and could take 4 attempts to get the unit to switch on.A getinge field service engineer (fse) was dispatched to investigate the issue.The fse advised the customer that a delay is required between multiple on/ off actions.The fse then noticed that the on-off switch was not switching clearly.So, in order to fix the issue, the fse replaced the cable assembly.The unit passed all functional and calibration tests.The unit was then put back into clinical use.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 15278205
• MDR Text Key: 305258151
• Report Number: 2249723-2022-02138
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• UDI-Public: 10607567112541
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Date Manufacturer Received: 08/05/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1