MAUDE Adverse Event Report: DATASCOPE CORP. CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Output below Specifications (3004); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.The low vacuum alarm was caused by pump heads being reversed.The fse corrected pump head direction and the fault alarm cleared.The unit passes all functional and safety tests except battery run time.The batteries failed the runtime test.The getinge fse was told that the customer will replace batteries if needed on their own.The customer was advised that, getinge does not recommend the use of non-original equipment manufactured (non-oem) parts and cannot guarantee the performance of units making use of non-oem parts.The unit was returned to customer and not cleared for clinical use at this time.The biomedical engineer of the facility later on advised that, the unit was left unplugged and was not fully charged when the fse worked on it.The biomed had been running it the previous day on and off of battery power and had left it plugged into an electrical safety analyzer which was left shut off overnight.The fse was informed of this at the time.After leaving the unit to fully charge, a pm was performed and it passed the battery run time test and pm.The batteries were replaced (b)(6) 2018 and were not bad, the fse tested them when they were depleted.The unit has been returned to service.

Event Description

It was reported that during preventative maintenance (pm) performed by the customer's biomed, the cs300 intra-aortic balloon pump (iabp) generated a "low vacuum" and fault code #61.There was no patient involved and no adverse event reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 14 philips parkway; montvale NJ 07645
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 8806823
• MDR Text Key: 151576130
• Report Number: 2249723-2019-01129
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/18/2019

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: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2007
• 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