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

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 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

Stryker has forwarded this complaint information to (b)(4), the manufacturer of the masks.Device not returned.

Event Description

The user facility reported that after reprocessing of the masks, it was found that 8 masks had broken bands.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 after reprocessing of the masks, it was found that 8 masks had broken bands.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

Additional info h6.Device not returned.

Event Description

The user facility reported that after reprocessing of the masks, it was found that 8 masks had broken bands.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• 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 Key: 10223858
• MDR Text Key: 197921564
• Report Number: 0001811755-2020-01614
• Device Sequence Number: 1
• Product Code: QKY
• UDI-Device Identifier: 00690455440003
• UDI-Public: 00690455440003
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 44000-R
• Device Catalogue Number: 44000-R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1