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 Problems Break (1069); Power Problem (3010); Device Fell (4014)

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

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) reported that the customer stated that there were no issues with the iabp itself, and that they needed a replacement removable power supply.The fse placed the order for part and confirmed delivery.Later the fse spoke with the customer and confirmed that the replacement removable power supply was functioning properly with the iabp.The reported complaint has been resolved over the phone.No evaluation necessary.

Event Description

It was reported that the ac adapter of the cardiosave intra-aortic balloon pump (iabp) needed to be replaced.There was no patient involvement, and no adverse event reported.It was later reported and clarified that the customer stated that the removable a/c power supply was accidently dropped during a transport and sustained damage rendering it non-functional.The customer stated there that there were no issues with the cardiosave iabp itself.

Manufacturer Narrative

H6 (medical device - problem code, type of investigations -4111).Analysis of production: (3331) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110) the overall 24 month product complaint trend data for the period (may-2019 through apr-2021) was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111) communication/interviews were performed to confirm the replacement removable power supply was functioning properly.

• 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
• MDR Report Key: 11820444
• MDR Text Key: 250818682
• Report Number: 2249723-2021-01003
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Patient Sequence Number: 1