MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVEHYBRID INT TYPE E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problem Charging Problem (2892)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse confirmed the iabp was not seated in the cart properly which prevented the battery from charging.Once the iabp was reseated, it began charging properly.The iabp functions as intended.(b)(6).

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) batteries would not charge, even when connected to network.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Unit is with the customer.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

The unit has been cleared for clinical use.The full address of the event site in block e1 was shortened due to field character limit; the full address is (b)(6).The telephone# for initial reporter is (b)(6).

Manufacturer Narrative

Updated fields; b4, g3, g6, g7, h2, h6, h10, h11.Corrected fields: g1, h4, h6 (health effect - clinical code, investigation conclusions).

Event Description

N/a.

• Brand Name: CARDIOSAVEHYBRID INT TYPE E/F 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: 11563088
• MDR Text Key: 243382925
• Report Number: 2249723-2021-00602
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/27/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 02/23/2022; 05/11/2022; 12/27/2022
• Supplement Dates FDA Received: 03/21/2022; 06/02/2022; 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1