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 Audible Prompt/Feedback Problem (4020); Activation Problem (4042)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to investigate the reported issue and upon initial inspection the stm found that the unit would not boot up in operational mode but was able to get the unit boot up in service mode.It was found the error code 7 (communications faults) and numerous error code 118 (inform bit of continuous bit failure from a remote vas).As per service manual the stm checked the drive manifold, the solenoid control board and the executive processor board.Since the problem has been intermittent, the stm replaced all 3 components rather than replace one and return for the other components latter.The stm also found the 9 volt battery to be dead and replaced it.Subsequently, performed calibration of all the transducers and regulators.Once calibration was completed, a complete system checkout was performed and then ran the pump on the trainer for a couple hours with no errors.The stm left the unit running for the night and checked back with the biomed in the morning to ensure no errors have occurred.Since unit ran without error overnight, the iabp was cleared for clinical use.(b)(6).

Event Description

It was reported that during start up, there was a loud beep in the cardiosave intra-aortic balloon pump (iabp) and would not go to start up screen.There was no harm or injury to the patient and no adverse event was reported.

Event Description

It was reported that during start up, there was a loud beep in the cardiosave intra-aortic balloon pump (iabp) and would not go to start up screen.There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

Updated fields: b4, b6, b7, d5, d11, g4, g7, h2, h6 (medical device - problem code, type of investigation, component codes, health effect - impact codes), h10, h11 corrected fields: d4 (model#).H4.An additional contact at the customer's site was provided: craig beck, biomedical engineer, phone number: (b)(6).Historical data analysis: (4109/102) 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: (4110/102) 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.Analysis of production: (3331/102) the device history records 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.

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 07430
• MDR Report Key: 11380582
• MDR Text Key: 233751430
• Report Number: 2249723-2021-00415
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1