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

Model Number 0998-00-0800-52

Device Problem Power Problem (3010)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp and indicated that all cables were intact during inspection.After checking for voltages and reconnecting the input power cable back to the power supply board, the unit started functioning normally on ac and it was charging battery.At this time is not known if the unit was cleared for clinical use.A supplemental report will be submitted if additional information is provided.

Event Description

It was reported that during use on a patient the cardiosave intra-aortic balloon pump (iabp) was connected to mains power supply (ac power led lit); however it was running on battery on hybrid mode.It is unknown if injury or harm occurred; however no adverse event was reported.

Manufacturer Narrative

A getinge field service engineer did not evaluate the iabp nor did any troubleshooting as mentioned in the initial emdr.A getinge authorized distributor's field service engineer (fse) was the one who evaluated the iabp and performed all the troubleshooting.A supplemental report will be submitted when our investigation is completed.

Manufacturer Narrative

It was reported by a new getinge authorized distributor that currently the iabp unit is with the previous distributor in their warehouse.The new getinge authorized distributor does not have any updates from the previous distributor regarding the status of the iabp unit.Additional information was requested from the new getinge authorized distributor with regard to the repair and status of the iabp; however, despite our best efforts, no repair information and no status of the iabp has been received.If any pertinent information is received in the future, a supplemental report will be submitted.Analysis of production: (3331) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported 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) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110) the overall 12 month product complaint trend data for the period oct 2019 through sep 2020 was reviewed.There were no triggers identified for the review period.

• Brand Name: CARDIOSAVE HYBRID INT TYPE G PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 10615480
• MDR Text Key: 209572061
• Report Number: 2249723-2020-01596
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• Reporter Country Code: KU
• 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: 11/19/2021

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: Health Professional
• Device Model Number: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 07/23/2021; 10/27/2021
• Supplement Dates FDA Received: 08/16/2021; 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1