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

Model Number 0998-00-0800-55

Device Problem Failure to Charge (1085)

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

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: (10/213).A getinge field service engineer (fse) was dispatched to evaluate this unit and performed a functional check and tests were not able to detect any anomaly in operation.The fse informed the customer that the batteries are charged individually and not simultaneously.Unit passed all functional and safety test per factory specifications.The iabp was released to the customer and cleared for clinical service.Upon completion of our investigation, a supplemental report will be submitted.The full name of the event site was shortened due to field character limit; the full name is (b)(6).

Event Description

It was reported that during system start up, one of the batteries in the cardiosave intra-aortic balloon pump (iabp) was not charging, there was no patient involvement and no adverse event reported.

Event Description

N/a.

• 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: 12069897
• MDR Text Key: 265590229
• Report Number: 2249723-2021-01357
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

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: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: N/A.