MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/23/2017

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit was not required to be reviewed per sop (b)(4) since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) evaluated the iabp and was unable to duplicate the reported error message "iab disconnected".In addition, the fse reported that the log file showed no faults but alarm file did show this alarm.With regard to the report from the customer that the unit shut down during use, upon inspection the fse found that the unit was not charging as green indicators were not present while unit was plugged in to wall outlet.The power switch located next to power cord was switched to the "off" position.However, the power parameter log shows the unit was fully charged on (b)(6) 2017 which indicates switch was in the "on" position and the discharge happened after that time as recorded in the log which indicates the switch was in "off" position.The fse tested the charging circuit battery and the run time was 3 hours and 5 minutes before unit was totally discharged.Battery warning alarm was displayed for 50 minutes before unit discharged.Fse determined that the autofill error was not a correct description as per the iabp's alarm log.

Event Description

Initially, customer reported that while in use on a patient, the iabp which was a rental pump, generated an autofill failure.When asked if there was any injury to the patient, the customer said he did not know but that the incident was going to be reported to the state.Subsequently, the company field service engineer (fse) reported that when he visited customer site on 5/23/2017 everyone used the term "patient incident", and so he believes there was patient harm.However, when the fse enquired what was the patient incident, the customer would not provide additional information.Fse also advised that error logs show iabp disconnected, and that the service tag the hospital uses to identify broken equipment says the unit turned off during treatment while error iabp disconnect was displayed.At this time, we are not sure if there was indeed patient harm and have contacted the customer for more information.

Manufacturer Narrative

08/03/2017 09:58 am (gmt-4:00) added by (b)(4) (pid-(b)(4)): this a correction to the previously reported dhr statement discovered today upon further review of the record, which should read as follows: the production device history record (dhr) for this iabp unit was reviewed and no non-conformance's related to the reported event were noted.

Event Description

Initially, customer reported that while in use on a patient, the iabp which was a rental pump, generated an auto-fill failure.When asked if there was any injury to the patient, the customer said he did not know but that the incident was going to be reported to the state.Subsequently, the company field service engineer (fse) reported that when he visited customer site on (b)(6)2017 everyone used the term "patient incident", and so he believes there was patient harm.However, when the fse enquired what was the patient incident, the customer would not provide additional information.Fse also advised that error logs show iabp disconnected, and that the service tag the hospital uses to identify broken equipment says the unit turned off during treatment while error iabp disconnect was displayed.At this time, we are not sure if there was indeed patient harm and have contacted the customer for more information.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 6643347
• MDR Text Key: 77642738
• Report Number: 2249723-2017-00028
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other