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

Model Number N/A

Device Problems Flare or Flash (2942); Device Contamination with Chemical or Other Material (2944); Power Problem (3010)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2019

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 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 and a new power supply was fitted and the device left to run under testing for the weekend.The iabp has not yet been returned to the customer or cleared for clinical use.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that a power supply issue occurred on a cs300 intra-aortic balloon pump (iabp).It is unknown under which circumstances this event occurred or if there was any patient involvement; however there was no adverse event reported.

Event Description

It was reported that while the cs300 intra-aortic balloon pump (iabp) was plugged in during set up, the mains connection got very hot.The main inlet area reportedly went on fire; large blue flame and burning/melting of the mains cable in the process.Once spotted, the iabp unit was powered off and the user rang for service.There was no patient involvement, as the unit was being set up for the next case.The customer later reported that they suspect saline ingress around the mains inlet.No harm, serious injury or death was reported.The following description below was reported to us by hpra via medical devices adverse incident user report relating to the above medical device (previously submitted to fda under mfg report number 2249723-2019-01780): the report outlines "on the 2nd-oct an electrical fire was reported in catherisation lab 1, guh.A flame and burning smell was reported from the maquet intraaortic balloon pump (iabp) at the mains receptacle (device end).The resulting flame tripped the power source where the maquet device was plugged in.There was no patient or staff injuries reported.The device was removed and quarantined, a review by clinical engineering found the ac receptacle at the machine end to be substantially burnt.The device has since been removed by the company and we are awaiting a report on the cause of the damage." no adverse event was reported.

Manufacturer Narrative

The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and reported a power supply issue.To address the failure, the fse replaced the suspected part with a new power supply and mains cable.The iabp was tested over a few days and a preventative maintenance was performed by the getinge fse.The iabp unit was returned to the customer and cleared for clinical use.The suspected power supply assembly and mains cable were collected and returned to the getinge workshop for shipment to the manufacturer for failure investigation.A supplemental report will be submitted when additional information is made available.

Event Description

It was reported that while the cs300 intra-aortic balloon pump (iabp) was plugged in during set up, the mains connection got very hot.The main inlet area reportedly went on fire; large blue flame and burning/melting of the mains cable in the process.Once spotted, the iabp unit was powered off and the user rang for service.There was no patient involvement, as the unit was being set up for the next case.The customer later reported that they suspect saline ingress around the mains inlet.No harm, serious injury or death was reported.The following description below was reported to us by hpra via medical devices adverse incident user report relating to the above medical device (previously submitted to fda under mfg report number 2249723-2019-01780): the report outlines "on the 2nd-oct an electrical fire was reported in catherisation lab 1, guh.A flame and burning smell was reported from the maquet intraaortic balloon pump (iabp) at the mains receptacle (device end).The resulting flame tripped the power source where the maquet device was plugged in.There was no patient or staff injuries reported.The device was removed and quarantined, a review by clinical engineering found the ac receptacle at the machine end to be substantially burnt.The device has since been removed by the company and we are awaiting a report on the cause of the damage." no adverse event was reported.

Manufacturer Narrative

The suspected faulty power supply was returned to getinge's national repair center (nrc) for failure analysis.A senior technician of the nrc inspected the power supply and found charring and damage to the three prong male input connector where the ac input power cord is plugged into.There was also an excessive amount of dust build up inside the power supply.The technician also inspected the line cord and found the molded plug missing and the female end that plugs into the ac input connector of the power supply was charred.The power supply was not able to be tested due to the damage to the ac input connector and possible saline damage to components inside the power supply."the customer reported that they suspect saline ingress around the mains inlet.No harm, serious injury or death was reported." both the power supply and line cord will be scrapped and retained in the nrc per procedure.

Manufacturer Narrative

Updated fields: date of report, pma/510k, if follow-up, what type (evaluation method codes).

Event Description

It was reported that while the cs300 intra-aortic balloon pump (iabp) was plugged in during set up, the mains connection got very hot.The main inlet area reportedly went on fire; large blue flame and burning/melting of the mains cable in the process.Once spotted, the iabp unit was powered off and the user rang for service.There was no patient involvement, as the unit was being set up for the next case.The customer later reported that they suspect saline ingress around the mains inlet.No harm, serious injury or death was reported.The following description below was reported to us by hpra via medical devices adverse incident user report relating to the above medical device (previously submitted to fda under mfg report number 2249723-2019-01780): the report outlines "on the 2nd-oct an electrical fire was reported in catherisation lab 1, guh.A flame and burning smell was reported from the maquet intraaortic balloon pump (iabp) at the mains receptacle (device end).The resulting flame tripped the power source where the maquet device was plugged in.There was no patient or staff injuries reported.The device was removed and quarantined, a review by clinical engineering found the ac receptacle at the machine end to be substantially burnt.The device has since been removed by the company and we are awaiting a report on the cause of the damage." no adverse event was reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 9239751
• MDR Text Key: 190208456
• Report Number: 2249723-2019-01716
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• 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: 0998-00-3023-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1