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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 FLUID WARMER; SYSTEM, THERMAL REGULATING

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SMITHS MEDICAL ASD, INC. LEVEL 1 FLUID WARMER; SYSTEM, THERMAL REGULATING Back to Search Results
Model Number L1-CW-220V
Device Problems Device Alarm System (1012); Pumping Stopped (1503)
Patient Problem Hypothermia (1915)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
Information was received indicating that a smiths medical heater automatically switched off when in used.The occlusion and service indication alarms went off.They reset the device per the manual but still the alarms remained.The device stopped warming and kept alarming.The patient got hypothermia as a result.No other adverse events reported.
 
Event Description
A technical support engineer with the company organized a meeting with the customer on 26-nov-2020 in an attempt to trouble shoot the reported product problem.The support engineer noted that the occlusion/maintenance alarm was activated when the hose was disconnected from the unit.This was also reported by the customer.The support engineer noted further that this was an expected outcome that is outlined in the instructions for use (ifu) for the device.In addition to the above, the support engineer also discovered a secondary problem that was not reported by the customer.When the device was operated in the ambient state (i.E.When the unit blows ambient air into the blanket) an occlusion alarm was produced.This was a fault that should not have occurred.The evaluation of the affected device at the investigation site is still pending.A supplemental report will be sent after the device evaluation is completed.
 
Manufacturer Narrative
Other, other text: b5: updated with additional information.
 
Event Description
A technical support engineer with the company organized a meeting with the customer on (b)(6) 2020 in an attempt to trouble shoot the reported product problem.The support engineer noted that the occlusion/maintenance alarm was activated when the hose was disconnected from the unit.This was also reported by the customer.The support engineer noted further that this was an expected outcome that is outlined in the instructions for use (ifu) for the device.In addition to the above, the support engineer also discovered a secondary problem that was not reported by the customer.When the device was operated in the ambient state (i.E.When the unit blows ambient air into the blanket) an occlusion alarm was produced.This was a fault that should not have occurred.The evaluation of the affected device at the investigation site is still pending.A supplemental report will be sent after the device evaluation is completed.
 
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Brand Name
LEVEL 1 FLUID WARMER
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key11008887
MDR Text Key221452427
Report Number3012307300-2020-19951
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup,Followup
Report Date 02/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberL1-CW-220V
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/17/2020
Initial Date FDA Received12/15/2020
Supplement Dates Manufacturer Received01/29/2021
01/29/2021
Supplement Dates FDA Received02/27/2021
02/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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