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

Model Number N/A

Device Problem Circuit Failure (1089)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per getinge standard operating procedure since the serial number for the unit was not provided.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested from the customer with regard to the return of the defective part.A supplemental report will be submitted if this information is provided to us.(b)(6).

Event Description

It was reported the customer received a defective solenoid drive board on a sales order.There was no patient involved and no adverse event was reported.

Manufacturer Narrative

The defective drive manifold assembly was sent to getinge's national repair center (nrc) for evaluation.A supplemental report will be sent upon completion of this evaluation.

Event Description

It was reported the customer received a defective drive manifold assembly on a sales order.This is an out-of-box (oob) failure.There was no patient involved and no adverse event was reported.

Event Description

It was reported the customer received a defective drive manifold assembly on a sales order.This is an out-of-box (oob) failure.There was no patient involved and no adverse event was reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10.A getinge's national repair center representative reported that the suspected solenoid drive manifold board was handed over to sustaining engineering department as this is a part that is investigated by them.A senior electronic technician of the sustaining engineering department installed the suspected solenoid drive manifold board in the cs100 test fixture, and autofill and safety disk tests were performed per procedure and passed, no failures were reported.In addition k6, k6a, k7, k8 were inspected for any mechanical or visual defects, and no defects were found.K6, k6a, k7, k8 leak test was also performed and no failure was found.Sustaining engineering was unable to duplicate the reported failure.The solenoid drive manifold board will be discarded per procedure.In addition, a good faith efforts (gfe) attempt was made to the customer to obtain additional information on this complaint event.The customer reported that they received a new solenoid drive manifold board.No further investigation is required.

• 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: 9527804
• MDR Text Key: 191562990
• Report Number: 2249723-2019-02108
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 02/05/2020; 03/28/2020
• Supplement Dates FDA Received: 02/28/2020; 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1