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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY VISTAXL MONITOR; PHYSIOLOGICAL MONITORING SYSTEM
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DRAEGER MEDICAL SYSTEMS, INC INFINITY VISTAXL MONITOR; PHYSIOLOGICAL MONITORING SYSTEM Back to Search Results
Model Number MS18986
Device Problem Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2021
Event Type  malfunction  
Event Description
It was reported that a fire incident occurred with a draeger vista xl monitor being used with a counterfeit draeger battery (with dräger logo stamped on the label) that was installed by a non authorized 3rd party.No adverse patient impact was reported.Note that the following is provided in the vista xl instructions for use: warning only the items indicated on the list of accessories in the ¿accessories¿ chapter have been tested and approved to be used with the device.Accordingly it is strongly recommended that only these accessories be used in conjunction with the specific device.Otherwise the correct functioning of the device may be compromised.Caution: it is strongly recommended that you use batteries that are provided by dräger medical.The use of non-approved batteries may damage the device.Note: cables and accessories not specified within the instructions for use are not authorized.Using other cables and/or accessories may adversely impact safety, performance and electromagnetic compatibility (increased emission and decreased immunity).Under approved accessories: external battery pack (sealed lead acid) 5592097.
 
Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
 
Event Description
It was reported that a fire incident occurred with a draeger vista xl monitor being used with a counterfeit draeger battery (with dräger logo stamped on the label) that was installed by a non authorized 3rd party.No adverse patient impact was reported.
 
Manufacturer Narrative
A draeger service technician evaluated the device and root cause was identified as unintentional use of a counterfeit draeger battery.Photos of the battery that caused the reported fire were compared to that of the draeger battery and the following observations were made: (1) the counterfeit battery was wrapped in a blue shrink wrap, while draeger battery specifications indicate that the battery should be covered in an orange shrink wrap and (2) the counterfeit battery lacked the circuit protection board that is found in the draeger battery.Note that the following is provided in the vista xl instructions for use: caution: it is strongly recommended that you use batteries that are provided by draeger medical.The use of non-approved batteries may damage the device.Warning only the items indicated on the list of accessories in the ¿accessories¿ chapter have been tested and approved to be used with the device.Accordingly it is strongly recommended that only these accessories be used in conjunction with the specific device.Otherwise the correct functioning of the device may be compromised.Note: cables and accessories not specified within the instructions for use are not authorized.Using other cables and/or accessories may adversely impact safety, performance and electromagnetic compatibility (increased emission and decreased immunity).-under approved accessories: external battery pack (sealed lead acid) (b)(4).
 
Manufacturer Narrative
Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.
 
Event Description
It was reported that a fire incident occurred with a draeger vista xl monitor being used with a counterfeit draeger battery (with dräger logo stamped on the label) that was installed by a non authorized 3rd party.No adverse patient impact was reported.
 
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Brand Name
INFINITY VISTAXL MONITOR
Type of Device
PHYSIOLOGICAL MONITORING SYSTEM
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC
6 tech drive
andover MA
Manufacturer (Section G)
DRAEGER MEDICAL SYSTEMS, INC
6 tech drive
andover MA
MDR Report Key13238574
MDR Text Key285988743
Report Number1220063-2021-00036
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04049098003858
UDI-Public04049098003858
Combination Product (y/n)N
PMA/PMN Number
K070566
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMS18986
Device Catalogue NumberMS18986
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/16/2021
Initial Date FDA Received01/12/2022
Supplement Dates Manufacturer Received02/14/2022
02/14/2022
Supplement Dates FDA Received02/14/2022
06/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NA.; NA.; NA.
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