MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH SYSTEM98XT; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Component Incompatible (1108); Appropriate Term/Code Not Available (3191)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The suspected faulty pressure transducer has been requested to be returned to getinge's national repair center (nrc) for further investigation.A supplemental report will be submitted when additional information is provided to us.

Event Description

It was reported that the new pressure transducer installed by a getinge field service engineer (fse) into the system 98xt intra-aortic balloon pump (iabp) was not working out-of-the-box.This is an out-of- box failure of the pressure transducer.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that the new pressure transducer installed by a getinge field service engineer (fse) into the system 98xt intra-aortic balloon pump (iabp) was not working out-of-the-box.This is an out-of- box failure of the pressure transducer.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The full event site name in block e1 is: (b)(6).The suspected faulty pressure transducer was received at the national repair center (nrc).The nrc handed over the part to sustaining engineering.A supplemental report will be submitted when additional information is provided to us.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h6, h10.The suspected faulty pressure transducer was inspected by a sr.Electronic technician at the sustaining engineering, and no visual defects were found during visual inspection.In order to reproduce the failure, the suspect pressure transducer was installed in the cs100 test fixture, and the following tests were perform per procedure: volume test, safety disk leak test, k6, k6a, k7, k8 leak test, safety vent test, pneumatic performance test, autofill calibration.All tests passed.The sr.Electronic technician then ran the test fixture that was pumped at 120bpm for 24 hours and no failures were reported.The sr.Electronic technician at the sustaining engineering was unable to duplicate the reported failure.Per procedure, the pressure transducer will be discarded.

Event Description

It was reported that the new pressure transducer installed by a getinge field service engineer (fse) into the system 98xt intra-aortic balloon pump (iabp) was not working out-of-the-box.This is an out-of- box failure of the pressure transducer.There was no patient involvement, and no adverse event reported.

• Brand Name: SYSTEM98XT
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11251739
• MDR Text Key: 230237224
• Report Number: 2249723-2021-00168
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K961509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2021

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: N/A
• Device Catalogue Number: 0998-00-0479-55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 02/01/2021; 03/02/2021
• Supplement Dates FDA Received: 02/24/2021; 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1