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

Model Number 0998-00-0800-31

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

No repair information has been provided at this time.A supplemental report will be submitted upon receipt of additional information.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was not going into service mode.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Manufacturer Narrative

Updated sections: b4, e4, h2, g3, g6, h10, h11.Corrected sections: b5, b6, b7, d5, d10, h6(health impact code).

Event Description

It was reported that during routine start up check the cardiosave intra-aortic balloon pump (iabp) was not going into service mode.There was no patient involvement.

Manufacturer Narrative

Updated fields - b4, d9, e1(site country), g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11 corrected fields: d5 additional information: e1( event site postal code: 4740, event site state: qld) a getinge field service engineer (fse) evaluated the iabp and found that the monitor is faulty, so replaced the same.Fse performed the electrical safety testing as per standard.All functional safety checks have been made to meet factory specifications.The iabp returned to the customer for use.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE I (AU)
• 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: 13078679
• MDR Text Key: 286666800
• Report Number: 2249723-2021-02946
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109053
• UDI-Public: 10607567109053
• Combination Product (y/n): N
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

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: Other
• Device Model Number: 0998-00-0800-31
• Device Catalogue Number: 0998-00-0800-31
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 10/07/2022; 02/21/2024
• Supplement Dates FDA Received: 10/18/2022; 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1