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

Model Number 0998-00-0800-53

Device Problem Circuit Failure (1089)

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

Event Date 03/23/2022

Event Type  malfunction  

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), it was observed that the cardiosave intra-aortic balloon pump (iabp) had the front end board port damaged.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Testing of actual/suspected device : during a preventative maintenance (pm) service, the getinge field service engineer (fse) discovered that the customer's front end board blood pressure port had cable abuse done to it.There was plastic left in the port from the damaged cable.The fse removed the plastic but the retaining clip in the port was damaged and would not allow another cable to be inserted.The fse replaced the front end board and unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.The full name of the initial reporter that is abbreviated in is (b)(6).The initial reporter named in 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).

Manufacturer Narrative

The suspected faulty front end board was returned to getinge.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

Manufacturer Narrative

Updated fields: e1 (site country), h6 (type of investigation, investigation findings, investigation conclusions).It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), it was observed that the cardiosave intra-aortic balloon pump (iabp) had the front end board port damaged.There was no patient involvement, and no adverse event reported.Fse reported customer's front end board blood pressure port had cable abuse done to it.There was plastic left in the port from the damaged cable.I removed the plastic but the retaining clip in the port was damaged and would not allow another cable to be inserted.I replaced the front end board and unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.The defective components were received for further investigation.The nrc verified the failure of a defective connector j2, which did not permit the blood pressure cable to seat correctly.The board failed testing.Retaining the board in the national repair center per procedure number: (b)(4) revision aj.The nrc verified the failure of a defective connector j2, which did not permit the blood pressure cable to seat correctly.The board failed testing.Retaining the board in the national repair center per procedure number: (b)(4) revision aj.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 14114192
• MDR Text Key: 289426173
• Report Number: 2249723-2022-00857
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 03/14/2024

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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 05/10/2022; 03/13/2024
• Supplement Dates FDA Received: 05/31/2022; 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.