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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STERIZONE VP4 STERILIZER; DECONTAMINATION SYSTEMS FOR N95 RESPIRATORS
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STRYKER INSTRUMENTS-KALAMAZOO STERIZONE VP4 STERILIZER; DECONTAMINATION SYSTEMS FOR N95 RESPIRATORS Back to Search Results
Model Number 44000-R
Device Problems Device Reprocessing Problem (1091); Degraded (1153)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2020
Event Type  malfunction  
Manufacturer Narrative
Stryker was unable to confirm the manufacturer of the masks involved in this reported event.Device not returned.
 
Event Description
The user facility reported that the sterilizer left a strong smell of residue on the masks after sterilization.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Event Description
The user facility reported that the sterilizer left a strong smell of residue on the masks after sterilization.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
Corrected data: g7 upon further investigation, the awareness date was clarified by the stryker representative.
 
Event Description
The user facility reported that the sterilizer left a strong smell of residue on the masks after sterilization.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
Device not returned.
 
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Brand Name
STERIZONE VP4 STERILIZER
Type of Device
DECONTAMINATION SYSTEMS FOR N95 RESPIRATORS
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10223949
MDR Text Key197611909
Report Number0001811755-2020-01617
Device Sequence Number1
Product Code QKY
UDI-Device Identifier00690455440003
UDI-Public00690455440003
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number44000-R
Device Catalogue Number44000-R
Was Device Available for Evaluation? No
Date Manufacturer Received10/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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