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

Model Number N/A

Device Problem Failure to Charge (1085)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) reported that the reported issue was resolved via telephone conversation with the customer's biomed.The fse troubleshot the iabp device over the phone and determined that iabp was functioning in 'rescue mode' and the iabp console was not fully seated in the hospital cart.Biomed fully seated the iabp console into the hospital cart and confirmed the a/c sign wave led on the hospital cart was illuminated and the battery indicator led was flashing indicating the batteries were being charged.The fse advised the customer / biomed to leave the iabp device plugged in and connected to a/c power overnight to allow the batteries to fully charge.The following day the fse spoke with the customer's biomed and confirmed both batteries were fully charged and indicated by the led's on the battery packs.The biomed also confirmed the lcd was indicating the batteries had a full charge, and that the iabp successfully powered on and the 'system test ok' message was displayed on the lcd.Iabp functioned correctly at this time and the batteries were properly charging.The fse advised the biomed that the iabp unit was safe for clinical function and cleared for clinical use.Physical site visit was not warranted at this time as reported complaint was resolved via phone call.Photos were provided by the biomed to the fse indicating proper function of the iabp device.Iabp was functioning in accordance with factory specifications, and at this time is cleared for clinical use.

Event Description

It was reported that during a routine check performed by the customer, it was identified that the cardiosave intra-aortic balloon pump (iabp) was having battery issues.One battery was draining and causing the iabp not to show full charge with the indicator.It was additionally reported that the iabp unit was showing "battery in use" even when it was plugged in.The little panel on the back was showing that it was plugged in but the batteries were not charging they were depleting.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Analysis of production: (3331) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr/lhr 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 ((b)(6) 2019 through (b)(6) 2021) was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111) communication/interviews were performed to obtain all possible information.

Event Description

N/a.

• 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: 11605411
• MDR Text Key: 243589736
• Report Number: 2249723-2021-00699
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• 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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Patient Sequence Number: 1