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 Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported during treatment, the cardiosave intra-aortic balloon pump (iabp) unit had module failure and pacing spikes for patients who do not have a pacemaker.

Manufacturer Narrative

Additional information: e1 (event site postal code- (b)(6)).It was reported that during use the cardiosave intra-aortic balloon pump (iabp) had fiber-optic sensor module failure alarm.There was patient involvement but no harm reported.Module failure and pacing spikes occur during treatment.During treatment, module failure is displayed and pacing is performed for patients who do not have a pacemaker.Gfe was performed to get additional information but no response received.As of now the investigation is closed, if any new information received in future related to part replacement will reopen the complaint and update it.There is no further information available.H3 other text : repair service details not provided.

Event Description

N/a.

Manufacturer Narrative

It was reported that during use the cardiosave intra-aortic balloon pump (iabp) had fiber-optic sensor module failure alarm.There was patient involvement but no harm reported.Module failure and pacing spikes occur during treatment.During treatment, module failure is displayed and pacing is performed for patients who do not have a pacemaker.A getinge field service engineer confirmed the device not repaired.

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: 18419267
• MDR Text Key: 331678146
• Report Number: 2249723-2023-05562
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2024

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: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 04/04/2024; 05/09/2024
• Supplement Dates FDA Received: 04/08/2024; 05/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1