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 Failure to Charge (1085); Off-Label Use (1494)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

The failure was observed by the end user, not charging batteries after an on transport operation, the customer performed the battery run test and batteries depleted.As per the biomed once plugged in to charge, the battery cycle would start, then stop.The getinge field service engineer (fse) performed the battery charging sequence and observed bay 1 battery charging and stopping, he removed the bay battery and charging sequence started on bay 2 battery.The issue was isolated to defective battery in bay 1 s/n(b)(4)).The customer supplied a battery from spare pump and installed and tested.The battery charging sequence operated to specifications.Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was having a battery charging issue.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

Upon review, it was observed that the repair information reported was incorrect and for an event reported under medwatch report 2249723-2021-01391.The repair for this reported event was cancelled.However, a getinge field service engineer (fse) was dispatched at a later date for a separate event which has been documented under medwatch report 2249723-2021-02537.The iabp unit was cleared for use and returned to the customer.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was experiencing a battery charging issue.It was noted that the battery charging sequence fails to resume after the iabp unit is re-connected to ac power while providing therapy to a patient.It was noted that the customer is using the iabp unit while patients are ambulatory while receiving therapy and the batteries are being depleted to various degrees before ac power is restored.There was no report of patient harm and no adverse event had been reported.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h6, h10.

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: 12062532
• MDR Text Key: 265587272
• Report Number: 2249723-2021-01344
• 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: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose