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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; BED,BASIC, SEMI ELECTRIC
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MEDLINE INDUSTRIES, LP Medline; BED,BASIC, SEMI ELECTRIC Back to Search Results
Model Number MDR107002E
Device Problems Melted (1385); Material Deformation (2976); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2022
Event Type  malfunction  
Manufacturer Narrative
According to the facility on (b)(6) 2022 'the patient that was using the bed stated that the bed stopped working and upon assessment, saw that the wall plug was burnt and the motor/wire was compromised'.Per the facility nothing else was plugged into the outlet and they deemed that the outlet was appropriate for use.Per the facility they were unable to visually confirm smoke or fire, but stated the plug was burnt.The device is available but has not been returned for evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
Event Description
According to the facility on (b)(6) 2022 'the patient that was using the bed stated that the bed stopped working and upon assessment, saw that the wall plug was burnt and the motor/wire was compromised'.
 
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Brand Name
Medline
Type of Device
BED,BASIC, SEMI ELECTRIC
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP
three lakes drive
northfield IL 60093
Manufacturer Contact
justin herrmann
three lakes drive
northfield, IL 60093
MDR Report Key16042959
MDR Text Key306086472
Report Number1417592-2022-00244
Device Sequence Number1
Product Code LLI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 12/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberMDR107002E
Device Catalogue NumberMDR107002E
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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