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 Problems Appropriate Term/Code Not Available (3191); Unexpected Shutdown (4019)

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

Event Date 11/19/2021

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) stopped working without errors.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Manufacturer Narrative

Device not accessible for testing at this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.Full event sie name: (b)(6) medical center.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) stopped working without errors.It was later clarified that the iabp unit had shut down unexpectedly.No patient harm or adverse event was reported.

Manufacturer Narrative

Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse confirmed that there were several errors in the logs (78,111,112,116 & n118) that pointed to the display communication or interruption to the display.The fse looked at the coiled cable and found it to be stretched and the connector at the video control board was pulled and stressed.The fse ordered a replacement coiled cable, then returned at a later date and replaced the coiled cable and tie clamp that holds the cable in place.Unrelated to the reported issue, the fse replaced the tidal volume disk as it was due for replacement.The fse completed all diagnostic, performance and safety tests with no errors or issues.The fse approved the unit for clinical use and returned to the customer.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields: b4,e1(site country),g3,g6,g7,h2,h4,h6(type of investigation, investigation findings, investigation conclusions),h10,h11.Corrected fields:d5,h2.

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: 13001886
• MDR Text Key: 288899513
• Report Number: 2249723-2021-02859
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.