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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OAKDALE LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
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OAKDALE LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION Back to Search Results
Model Number 8002950
Device Problems Device Emits Odor (1425); Fumes or Vapors (2529); Noise, Audible (3273)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It was reported that the device had a "burning smell" and the motor sounded like there is a "gear grinding inside".Patient involvement unknown.
 
Manufacturer Narrative
Other, other text: b3: date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
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Brand Name
LEVEL 1 FAST FLOW FLUID WARMER
Type of Device
WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
Manufacturer (Section D)
OAKDALE
3350 granada ave n
oakdale MN 55128
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key17233448
MDR Text Key318382476
Report Number3012307300-2023-06935
Device Sequence Number1
Product Code BSB
UDI-Device Identifier50695085829506
UDI-Public50695085829506
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK020043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8002950
Device Catalogue Number8002950
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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