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 Failure to Charge (1085)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.E1 event site name was shortened due to character limitations.The complete name is (b)(6) university.

Event Description

It was reported during a routine maintenance performed by the customer, the cs100 intra-aortic balloon pump (iabp) could not be charged.There was no harm reported.

Manufacturer Narrative

Updated fields: b4,e2,e3,g2,g3,g6,h2,h6,h10.Additional info received on 06/17/2024: customer occupation: head nurse of the intervention department.

Manufacturer Narrative

Updated fields - b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h10, h11.Corrected fields:h6 (health effect ¿ impact codes ).Additional information: e1 (event site postal code: (b)(6), event site state:(b)(6)).A getinge field service engineer (fse) on on-site inspection found that the power module was damaged and the ups battery was insufficient.Waiting for the customer to order accessories.On 6-1, the customer transferred to a maintenance contract 6-16, on-site repair, parts replacement completed, all performance tests were carried out on the equipment according to factory requirements, and the test results met the requirements and could be delivered to the customer for use.The customer retains the accessories and cannot return them.

• 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: 19072800
• MDR Text Key: 339783006
• Report Number: 2249723-2024-01433
• 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,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2024

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 Model Number: 0998-00-3013-45
• Device Catalogue Number: 0998-00-3013-45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 06/17/2024; 06/21/2024
• Supplement Dates FDA Received: 06/18/2024; 06/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1