• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300 INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATASCOPE MAHWAH CS300 INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3023-53
Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)
Patient Problems Death (1802); Brain Injury (2219)
Event Date 04/21/2016
Event Type  Death  
Manufacturer Narrative
The production device history record (dhr) for the iabp involved in the event was reviewed. There were no nonconformance noted in the dhr related to the reported event. The customer has requested service of the unit (cs300 iabp, s/n (b)(4)) involved in the event and as reported in this medwatch. The company service department has initiated contact with the customer to arrange for service of the unit. The customer has requested service of the unit (cs300 iabp, s/n (b)(4)) involved in the event and as reported in this medwatch. The company service department has initiated contact with the customer to arrange for service of the unit. The production device history record (dhr) for the iabp involved in the event was reviewed. There were no nonconformances noted in the dhr related to the reported event. (b)(4).
 
Event Description
It was initially reported by the customer that the unit would be generating an alarm for ¿gas loss¿ when in fact no leaks were detected by the customer and it was found that all connection were secure. The device was rebooted and worked per specifications, and used to complete therapy. On 10/07/2016 when the company representative called back to the customer to obtain additional information, the customer reported the patient had suffered ¿brain death¿. The customer did not provide any information on whether the brain death of the patient is attributed to the device or to the event. The unit has not been utilized in therapy since the event.
 
Manufacturer Narrative
As previously stated, multiple attempts were made to the customer to retrieve information regarding the patient and to retrieve a confirmation of the event, but were unsuccessful. Other individuals within the same department and who were contacted did not recollect any such event (i. E. Unit malfunction and patient adverse event). Further, the customer requested service on the unit allegedly involved in the event, and a full preventive maintenance (pm) was performed by the company service representative. The outcome of the pm revealed the unit was fully functional and conformed to factory specifications. The unit was returned to the customer for use.
 
Event Description
It was initially reported by the customer that the unit would be generating an alarm for ¿gas loss¿ when in fact no leaks were detected by the customer and it was found that all connection were secure. The device was rebooted and worked per specifications, and used to complete therapy. On (b)(6) 2016 when the company representative called back to the customer to obtain additional information, the customer reported the patient had suffered ¿brain death¿. The customer did not provide any information on whether the brain death of the patient is attributed to the device or to the event. The unit has not been utilized in therapy since the event. Multiple attempts were made to the customer to retrieve information regarding the patient and to retrieve a confirmation of the event, but were unsuccessful. Other individuals within the same department and who were contacted did not recollect any such event (i. E. Unit malfunction and patient adverse event).
 
Manufacturer Narrative
During follow up communication between the company representative and the customer, the customer reported that the patient did not experience an adverse event and there was no patient death associated with the device. The patient is currently on a transplant list. No further information was provided.
 
Event Description
It was initially reported by the customer that the unit would be generating an alarm for ¿gas loss¿ when in fact no leaks were detected by the customer and it was found that all connection were secure. The device was rebooted and worked per specifications, and used to complete therapy. On 10/07/2016 when the company representative called back to the customer to obtain additional information, the customer reported the patient had suffered ¿brain death¿. The customer did not provide any information on whether the brain death of the patient is attributed to the device or to the event. The unit has not been utilized in therapy since the event. Multiple attempts were made to the customer to retrieve information regarding the patient and to retrieve a confirmation of the event, but were unsuccessful. Other individuals within the same department and who were contacted did not recollect any such event (i. E. Unit malfunction and patient adverse event).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCS300 INTRA-AORTIC BALLOON PUMP (IABP)
Type of DeviceSYSTEM, 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 Key6062652
MDR Text Key58599908
Report Number2249723-2016-00032
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received12/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/27/2016 Patient Sequence Number: 1
-
-