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

Model Number 0998-00-0800-52

Device Problems Device Alarm System (1012); Alarm Not Visible (1022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit with trainer.No alarm or error were encountered, however, from recent faults list coded 77, 02 and 55 were found in the log records.500 hrs.Kit were requested to replaced on jan 25 during pm.Due to code 02 and 55, the executive processor board was recommended to replace as well.Unit was not released for use.Service was not completed.A supplemental report will be submitted when final service report becomes available.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had an alarm without any error displayed on the screen.The user swap the unit to a different iabp and continue with the treatment.There was no harm or injury to the patient and no adverse event was reported.

Manufacturer Narrative

(investigation findings, component codes, health effect ¿ impact codes, investigation conclusions), corrected fields: (medical device ¿ problem code) the getinge field service engineer (fse) returned to the customer's site at a later date and replaced the alarm daughterboard.Subsequently, the stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had an alarm without any error displayed on the screen.The user swap the unit to a different iabp and continue with the treatment.There was no harm or injury to the patient and no adverse event was reported.

Manufacturer Narrative

Analysis of production: (3331) 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) 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) the overall 24 month product complaint trend data for the period mar 2019 through feb 2021 was reviewed.There were no triggers identified for the review period.

• 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: 11377732
• MDR Text Key: 233454957
• Report Number: 2249723-2021-00391
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2021

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
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 02/11/2021; 11/01/2021
• Supplement Dates FDA Received: 04/07/2021; 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1