MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problem Failure to Charge (1085)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

Device not accessible for testing: (4117/213) device is not accessible for testing due to the customer not requesting repair service.At this time, the customer has not requested getinge to evaluate the iabp.Attempts are being made to obtain additional information with regard to the repair and status of the iabp unit.A supplemental report will be submitted if this information is provided to us.The full event site name in block e1 is (b)(6).Device not returned to manufacturer.

Event Description

It was reported that the battery was not charging on the cs300 intra-aortic balloon pump (iabp).No patient harm, serious injury or adverse event was reported.

Event Description

It was reported that during use on a patient, the battery was not charging on the cs300 intra-aortic balloon pump (iabp).No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Testing of actual/suspected device (10): a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and observed that the batteries in the iabp unit were non-oem batteries installed by the customer in june 2020.The fse installed new getinge batteries then completed all safety, functionality, and calibration checks.All tests passed to factory specifications and the iabp unit was cleared for clinical use and released to the customer.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g4, g7, g8, h2, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: d1, g1(contact person), h4.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• 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: 12144573
• MDR Text Key: 265574292
• Report Number: 2249723-2021-01475
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose