MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-45

Device Problem Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2024

Event Type  malfunction  

Event Description

It was reported that during inspection of the cs100 intra-aortic balloon pump (iabp) the customer found that the iabp displayed a battery maintenance alarm.The customer restarted the device and charged it, but it still could not be turned on and used after disconnecting the ac power.There was no injury caused.

Manufacturer Narrative

Corrected data: b5, b6, b7, d10, h6 (clinical and impact code) updated data: b4, e1(initial reporter and phone#), e2, e3, g2, g3, g6, h2, h10, h11.

Event Description

It was reported that before use, during inspection of the cs100 intra-aortic balloon pump (iabp) the customer found that the iabp displayed a battery maintenance alarm.The customer restarted the device and charged it, but it still could not be turned on and used after disconnecting the ac power.There was no patients involved.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 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: 19216897
• MDR Text Key: 341431676
• Report Number: 2249723-2024-01778
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107790
• UDI-Public: 10607567107790
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-45
• Device Catalogue Number: 0998-00-3013-45
• Date Manufacturer Received: 04/19/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1