MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STERIZONE VP4 STERILIZER; DECONTAMINATION SYSTEMS FOR N95 RESPIRATORS

Model Number	44000-R
Medical Device Problem Codes	Device Reprocessing Problem (1091); Device Emits Odor (1425)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker was unable to confirm the manufacturer of the masks involved in this reported event.Device not returned.
Event or Problem 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.
Additional Manufacturer Narrative
Corrected data: g7 upon further investigation, the awareness date was clarified by the stryker representative.
Event or Problem 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.
Additional Manufacturer Narrative
H3 other text : device not returned.
Event or Problem 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.

• Brand Name: STERIZONE VP4 STERILIZER
• Common Device Name: DECONTAMINATION SYSTEMS FOR N95 RESPIRATORS
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10223950
• Report Number: 0001811755-2020-01615
• Device Sequence Number: 10891371
• Product Code: QKY
• UDI-Device Identifier: 00690455440003
• UDI-Public: 00690455440003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2020

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
• Operator of Device: Health Professional
• Device Model Number: 44000-R
• Device Catalogue Number: 44000-R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 06/18/2020; 10/09/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 07/09/2020; 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1