MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Output below Specifications (3004)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.The getinge field service engineer (fse) replaced the scroll compressor.The stm completed the pm and then performed all functional and safety tests which passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.(b)(6).

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) that the compressor performance values were very close to the limits.There was no patient involvement, thus no adverse event was reported.

Manufacturer Narrative

After new information received by the getinge field service engineer (fse), repairs for the involved iabp are still on going.The customer was provided with a loaner iabp unit until repairs are completed.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) that the compressor performance values were very close to the limits.There was no patient involvement, thus no adverse event was reported.

Manufacturer Narrative

The getinge field service engineer (fse) that had started the repairs reported that the repairs were completed and that all functional and safety checks to meet factory specifications were performed.Unit passed all functional and safety test per factory specifications.The fes had replace the power management board and power supply monitor board, without success.The fse finally noticed that, previously replacing the compressor, he had pulled the whole pack of cables and almost unplugged the vcc connector on the backplane.It remained ¿almost¿ in place and finally got disconnected when the fse moved the unit to replace the mains cable reel.Once plugged back, the unit worked correctly.The 3 boards were finally not involved.The only defects on this unit were the compressor and the mains cable reel which were replaced.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) that the compressor performance values were very close to the limits.There was no patient involvement, thus no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYPE E/F PLG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 9575068
• MDR Text Key: 191566914
• Report Number: 2249723-2020-00055
• Device Sequence Number: 1
• Product Code: DSP
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• 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: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1