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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. LEVEL 1; 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 11/05/2020
Event Type  malfunction  
Manufacturer Narrative
Foreign: (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 (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.
 
Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to user interface.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
LEVEL 1
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
prime tower, business bay, p o
minneapolis, MN 55442
7633833310
MDR Report Key11008908
MDR Text Key221452278
Report Number3012307300-2020-19950
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeAE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 02/10/2022
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 Model NumberL1-CW-220V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2021
Is the Reporter a Health Professional? 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
07/09/2021
Supplement Dates FDA Received02/27/2021
02/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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