MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-55

Device Problem Failure to Run on Battery (1466)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to the customer's site.The fse replaced the power supply for low battery alarm.The fse also fnd its battery backup is less than 2 minute.So it¿s battery also need to replace.The fse checked and found that batteries are defective which should be purchase by customer.The fse asked customer to purchase the battery.The fse performed all calibration, functional and safety tests on iabp, which passed.The iabp was returned to customer and cleared for clinical use.Upon completion of our investigation, a supplemental report will be submitted.

Event Description

It was reported that prior to use, the cs100 intra-aortic balloon pump (iabp) was found to not work on battery mode.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The getinge fse has advised that the customer has ordered the batteries, but that the batteries are currently not available and out of stock.The iabp unit remains out of use pending battery replacement.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that prior to use, the cs100 intra-aortic balloon pump (iabp) was found to not work on battery mode.It was later reported by the customer that the iabp unit continuously alarmed "low battery" despite having sufficient battery back-up.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

In the initial emdr it was mentioned (in field h10) that the iabp was returned to customer and cleared for clinical use.This was entered in error.At the time the initial emdr was submitted, the iabp was not returned to customer and was not cleared for clinical use.The getinge field service engineer (fse) that evaluated the iabp as mentioned in the initial emdr and mfg follow-up #1, reported that the customer purchased the batteries and were replaced.The iabp was then kept under observation for 10 days to confirm proper operation of the unit.All functional and safety checks to meet factory specifications were performed, and all passed.The iabp was then returned to the customer and cleared for clinical use.Analysis of production: (3331) the device history record 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 aug 2019 through jul 2021 was reviewed.There were no triggers identified for the review period.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• MDR Report Key: 12314527
• MDR Text Key: 266263090
• Report Number: 2249723-2021-01791
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: 10607567107295
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2021
• Patient Sequence Number: 1