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

Model Number 0998-00-0800-45

Device Problem Failure to Charge (1085)

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

Event Type  malfunction  

Manufacturer Narrative

The distributors service engineer evaluated the iabp unit for the reported batteries that will not charge.To fix the issue service engineer replaced the batteries and the unit now charges, he then 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 address has been shortened due to field character limits and should read: (b)(6).

Event Description

It was reported that during installation of the cardiosave intra-aortic balloon pump (iabp) there was one of the batteries that was not charging, and not being recognized by the unit.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, g8, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: g1 (contact person ¿ mfg site).

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID, TYPE I 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: 12759339
• MDR Text Key: 282118988
• Report Number: 2249723-2021-02567
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: 10607567108421
• Combination Product (y/n): N
• Reporter Country Code: AL
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

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: Health Professional
• Device Model Number: 0998-00-0800-45
• Device Catalogue Number: 0998-00-0800-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1