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 Problems Premature Discharge of Battery (1057); Retraction Problem (1536)

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

Event Date 12/05/2023

Event Type  malfunction  

Event Description

It was reported during normal check of the cardiosave intra-aortic balloon pump (iabp) failing battery test and faulty power cord retractor.There was no patient involvement reported.

Manufacturer Narrative

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

Manufacturer Narrative

Event site postal code: (b)(6).A getinge field safety engineer (fse) was dispatched to evaluate the unit.The fse replaced the li-ion battery pack and reel, ac power cord to resolve the issue.The failure analysis and testing dept.Received part with a reported unit failure of a failed battery test and faulty power cord retractor.The fat performed a visual inspection and found the part to have a loose power cord and the reel not being able to retract.Tested continuity and one of the wires was faulty in the cord.Fat verified the reported failure but no root cause identified.Retaining the part in the failure analysis and testing department per procedure number 0002-07-d008 rev.Aq.

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: 18334832
• MDR Text Key: 330599196
• Report Number: 2249723-2023-05293
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109053
• UDI-Public: 10607567109053
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-31
• Device Catalogue Number: 0998-00-0800-31
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1