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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAFEDRAW TRANSDUCER SET; BLOOD PRESSURE TRANSDUCER SET
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SAFEDRAW TRANSDUCER SET; BLOOD PRESSURE TRANSDUCER SET Back to Search Results
Catalog Number 689440/JPB
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2021
Event Type  malfunction  
Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that the device was found to be leaking fluid.The device was replaced with a new unit.No patient injury to report.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
 
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Brand Name
SAFEDRAW TRANSDUCER SET
Type of Device
BLOOD PRESSURE TRANSDUCER SET
MDR Report Key12579999
MDR Text Key275045591
Report Number8020616-2021-00066
Device Sequence Number1
Product Code DSK
UDI-Device Identifier04589731125696
UDI-Public4589731125696
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2023
Device Catalogue Number689440/JPB
Device Lot NumberC2085744
Was Device Available for Evaluation? No
Date Manufacturer Received10/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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