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 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: (10 /213) a getinge field service engineer evaluated the iabp and was unable to verify report of battery charging issue.All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) failed leak test and there was also a battery charging issue.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.This submission is for the reported battery charging issue.A separate report will be submitted for the reported leak test failure.

Manufacturer Narrative

Mfg report number for leak test failure 2249723-2021-01400.

• 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12096122
• MDR Text Key: 265576407
• Report Number: 2249723-2021-01402
• 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: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose