MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

The full event site name in (b)(6) medical center.A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the unit and found dust on the fan and heard crackling sound while cleaning the fan.Repairs of the unit involved are ongoing.Additional information is being requested with regard to the repair and status of the iabp unit.A supplemental report will be submitted when this information is provided to us.

Event Description

It was reported that during patient use, the cardiosave intra-aortic balloon pump (iabp) overheated.No patient harm, serious injury or adverse event was reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h4, h6 (type of investigation), h10.Analysis of production: (3331/213) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) the overall 24 month product complaint trend data for the period mar 2020 through feb 2021 was reviewed.There were no triggers identified for the review period.

Manufacturer Narrative

The cardiosave intra-aortic balloon pump (iabp) was removed from the customer's facility and brought to the getinge japan office for additional evaluation.The getinge field service engineer (fse) replaced the fan cable assembly as the fan was observed to be damaged causing the iabp unit to overheat.Additionally, and unrelated to the reported issue, the 9v battery was replaced due to deterioration.Subsequently, the fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp is a rental unit, or fixed asset, at getinge japan and will not be returned to the customer.However, as all testing passed to factory specifications, the iabp unit was cleared for use.

Event Description

It was reported that during patient use, the cardiosave intra-aortic balloon pump (iabp) overheated.No patient harm, serious injury or adverse event was reported.

• 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 07430
• MDR Report Key: 11373143
• MDR Text Key: 233327155
• Report Number: 2249723-2021-00372
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1