• 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 UNKNOWN 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 UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Device Damaged Prior to Use (2284); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 04/11/2018
Event Type  malfunction  
Manufacturer Narrative
A production device history record (dhr) review is not required as this complaint is for an out-of-box part failure. A supplemental report will be submitted when additional information is made available.
 
Event Description
It was reported that during testing for field service corrective action the printed circuit board failed "out of the box ". The boards were checked and it was observed that the screen went to "initialization" then generated "electrical test failure #40/41". There was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
Corrected field: (the aware date in the initial emdr should read (b)(4) 2018).
 
Event Description
It was reported that during testing for field service corrective action the printed circuit board failed "out of the box. " the boards were checked and it was observed that the screen went to "initialization" then generated "electrical test failure #40/41". There was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
It was reported by a company representative that the necessary repairs were made and the iabp was functioning properly. Subsequently, the failed out of box part was returned to our national repair center for evaluation. A senior repair technician inspected the part and no visual damage was observed. The datasettes were installed into a main board of the cs100 test fixture and was tested to factory specifications per cs100 service manual. The datasettes failed testing and the reported failure was verified. The datasettes were then sent to the supplier for failure analysis per procedure and the supplier was able to verify the reported failure. They stated that u1 was not programmable and not cost effective to repair. The datasette was scrapped and retained in the nrc per procedure.
 
Event Description
It was reported that during testing for field service corrective action the printed circuit board failed "out of the box. " the boards were checked and it was observed that the screen went to "initialization" then generated "electrical test failure #40/41". There was no patient involvement and no adverse event was reported.
 
Event Description
It was reported that during testing for field service corrective action the printed circuit board failed "out of the box. " the boards were checked and it was observed that the screen went to "initialization" then generated "electrical test failure #40/41". There was no patient involvement and no adverse event was reported. This complaint has been identified as a duplicate to another. Please note that all relevant information regarding this event has been captured and submitted under mfg report # 2249723-2018-00935.
 
Manufacturer Narrative
This complaint has been identified as a duplicate to another. Please note that all relevant information regarding this event has been captured and submitted under mfg report # 2249723-2018-00935.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key7903439
MDR Text Key121718930
Report Number2249723-2018-01648
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 03/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received02/28/2019
Is This a Reprocessed and Reused Single-Use Device? No

-
-