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

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The getinge fse that encountered the issue reported that the latch was reset and the screws replaced.The equipment could then be taken out and replaced back into the cart the way it should be.Installation of the iabp equipment was finished off and has now been fixed, issue has been rectified.Commissioning of the iabp was completed and has been handed to the customer for clinical use.

Event Description

It was reported that a cardiosave intra-aortic balloon pump (iabp) was delivered to coventry hospital as brand new but required a repair.During drive/pressure regulator test the vacuum reading was too low.In order to adjust the reading the getinge field service engineer (fse) needed to remove the equipment from the cart.When the fse attempted this, the release handle beneath the equipment did not move.Upon closer inspection it was seen that the handle itself had not been properly fitted and so was unable to be used to remove the equipment from the cart.2 screws were also seen to be missing from the bottom of the iabp.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (evaluation method codes).

Event Description

It was reported that a cardiosave intra-aortic balloon pump (iabp) was delivered to coventry hospital as brand new but required a repair.During drive/pressure regulator test the vacuum reading was too low.In order to adjust the reading the getinge field service engineer (fse) needed to remove the equipment from the cart.When the fse attempted this, the release handle beneath the equipment did not move.Upon closer inspection it was seen that the handle itself had not been properly fitted and so was unable to be used to remove the equipment from the cart.2 screws were also seen to be missing from the bottom of the iabp.There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID INT TYPE G PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10320315
• MDR Text Key: 200254243
• Report Number: 2249723-2020-01158
• 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
• Report Date: 08/11/2020

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1