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 Problem Battery Problem (2885)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.Upon arrival to the customer's site,the stm observed that the customer's biomed had plugged the iabp unit into the ac outlet.The iabp unit was observed to be charging, and the batteries were fully charged.The stm was unable to reproduce the reported issue.The stm inspected the cables and cart connections and replaced the power management board as a precautionary measure.The stm completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.

Event Description

It was reported that the battery for the cardiosave intra-aortic balloon pump (iabp) was dead.It was later clarified that the batteries were found to be not charged.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

Updated fields: a1, b3, b4, b5, d4(version or model #), e1(initial reported), g3, g6, h2, h6, h10.

Event Description

It was reported that before use, the battery for the cardiosave intra-aortic balloon pump (iabp) was dead.It was later clarified that the batteries were found to be not charged.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Analysis of production: (3331/213) 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/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) the overall 12 month product complaint trend data for the period (dec 2019 through nov 2020) was reviewed.There were no triggers identified for the review period.

• 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 07430
• MDR Report Key: 10992338
• MDR Text Key: 220956718
• Report Number: 2249723-2020-02121
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1