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

Model Number 0998-00-0800-53

Device Problem Device Emits Odor (1425)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2022

Event Type  malfunction  

Manufacturer Narrative

The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is: (b)(6).The full name of the of the event site has been shortened due to field character limit and should read: (b)(6).Testing of actual/suspected device ((b)(4)): the fse opened unit, inspected and reseated all circuit bds.The fse visually inspected wiring and connectors.No issues noted.The fse then reassembled unit and ran on test balloon for several hours with no issues noted.Smell was no longer present.The unit passed all functional and safety tests according to factory specifications.Iabp was returned to customer and cleared for clinical use.

Event Description

It was reported that during preventative maintenance (pm) they smelled burning smell from the console of the cardiosave intra aortic balloon pump.There was no patient involvement and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID DOMESTIC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 14338479
• MDR Text Key: 291230299
• Report Number: 2249723-2022-01092
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/04/2022

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: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-65
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1