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

Model Number N/A

Device Problems Device Emits Odor (1425); Flare or Flash (2942)

Patient Problem 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 unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint.At this time, there is no record that customer has requested getinge to service or evaluate the involved iabp unit.An email has been sent to the customer in efforts to gather further information regarding the event and to request that any suspected faulty parts be returned to the manufacturer for further investigation.A supplemental report will be submitted when additional information is made available.

Event Description

It was reported that on the 2nd-oct an electrical fire was reported in catherisation lab 1, guh.A flame and burning smell was reported from the maquet intra-aortic balloon pump (iabp) at the mains receptacle (device end).The resulting flame tripped the power source where the maquet device was plugged in.It is unknown if a patient was directly involved; however, there were no patient or staff injuries reported.The device was removed and quarantined.No adverse event was reported.

Event Description

We have confirmed that this complaint report was duplicated in our system.Please note that all relevant information for this event was captured and submitted under the mfg report #2249723-2019-01716.It was reported that on the 2nd-oct an electrical fire was reported in catherisation lab 1, guh.A flame and burning smell was reported from the maquet intra-aortic balloon pump (iabp) at the mains receptacle (device end).The resulting flame tripped the power source where the maquet device was plugged in.It is unknown if a patient was directly involved; however, there were no patient or staff injuries reported.The device was removed and quarantined.No adverse event was reported.

Manufacturer Narrative

Subsequent to submission of the initial report, we received confirmation that this complaint was duplicated in our system.We initiated the initial report mfg report number 2249723-2019-01780 based on a medical device user report received via hpra.However, it has been confirmed that there was a pre-existing complaint and report submitted under mfg report #2249723-2019-01716.A follow-up report has been submitted to update the information related to this event.Please refer to mfg report #2249723-2019-01716 for further details of this event.

• 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: 9297740
• MDR Text Key: 165643288
• Report Number: 2249723-2019-01780
• 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
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• 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-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1