MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problem Failure to Charge (1085)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: (10/213) a getinge field service engineer (fse) evaluated the iabp for the reported system message "unusable battery detected in bay # 2", the fse confirmed the battery was indeed defective and would not charge in either bay.To fix the issue the fse installed the replacement battery provided by the customer passed all battery operation, function check and run time.He performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.The full event site name is (b)(6) medical center.

Event Description

It was reported that the cardiosave intra-aortic pump (iabp) displayed unusable battery detected in bay #3, no trigger and safety disk due for replacement.It unknown if there was patient involvement however, no adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp for the reported system message "unusable battery detected in bay # 2", the fse confirmed the battery was indeed defective and would not charge in either bay.To fix the issue the fse installed the replacement battery provided by the customer passed all battery operation, function check and run time.He performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had an unusable battery.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• 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: 12202492
• MDR Text Key: 262645187
• Report Number: 2249723-2021-01576
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Sex: Prefer Not To Disclose