• 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 CS100 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 CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3013-53
Device Problems Loss of Power (1475); Device Inoperable (1663)
Patient Problem Death (1802)
Event Date 05/31/2017
Event Type  Death  
Manufacturer Narrative
The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed. There were no non-conformances in the production dhr related to the reported event. On 18-july-2017, the customer biomed reported that the iabp unit has been quarantined in the office since the event. They tried exchanging the safety disk and balloon catheter with known good ones but the issue persisted. Repairs will be made at the discretion of the department. If additional information is provided, we will report the information accordingly.
 
Event Description
A company representative reported that they were at (b)(6) hospital on (b)(6) 2017, and a comment was made to them in the cath lab that the operating room (or) had used a cs100 intra-aortic balloon pump (iabp) on a patient and the pump malfunctioned and stopped working. The company representative's calls to the biomed were not returned. The pump is a cs100 and maquet/getinge did not work on this pump. The customer has a service contract with ge biomed group. The company representative was unable to locate the pump at the hospital. The company rep reached out to the perfusionist who told them that the pump was taken to the biomed and he was told that there was something wrong with the disk. The company rep did update their service territory manager (stm). (b)(6) hospital was fully aware of the end of service of cs100s by maquet/getinge on 31-dec-2015. The company rep was unable to get any facts pertaining to the patient except that the patient was "very sick". The customer never notified the company rep or their service tm of this incident. No adverse event was reported at the time of the initial report. It was later reported on 18-july-2017 that the patient subsequently died. An email has been sent to the customer to obtain additional information.
 
Manufacturer Narrative
(b)(4). On(b)(6) 2017, the customer's biomed reported that she was told that the patient did pass away while in the hospital; however it was not due to the procedure or incident. The patient passed away due to pre- existing conditions - no additional patient information was provided. A maquet balloon was used during the procedure. The unit was not repaired and was retired from use. The customer's biomed has confirmed that the patient's death that occurred was not attributed to the iabp device or iabp therapy. The iabp unit has been taken out of service due to end of life problem.
 
Event Description
A company representative reported that they were at (b)(6) hospital on (b)(6) 2017, and a comment was made to them in the cath lab that the operating room (or) had used a cs100 intra-aortic balloon pump (iabp) on a patient and the pump malfunctioned and stopped working. The company representative's calls to the biomed were not returned. The pump is a cs100 and maquet/getinge did not work on this pump. The customer has a service contract with ge biomed group. The company representative was unable to locate the pump at the hospital. The company rep reached out to the perfusionist who told them that the pump was taken to the biomed and he was told that there was something wrong with the disk. The company rep did update their service territory manager (stm). (b)(6)hospital was fully aware of the end of service of cs100s by maquet/getinge on (b)(6) 2015. The company rep was unable to get any facts pertaining to the patient except that the patient was "very sick". The customer never notified the company rep or their service tm of this incident. No adverse event was reported at the time of the initial report. It was later reported on (b)(6) 2017 that the patient subsequently died. An email has been sent to the customer to obtain additional information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCS100
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 Key6792267
MDR Text Key82618494
Report Number2249723-2017-00274
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031636
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
Report Date 09/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-3013-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received09/11/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/16/2004
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: 08/14/2017 Patient Sequence Number: 1
-
-