MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MV3; BARIATRIC BED

Catalog Number	5900000001
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 1 malfunction event, where it was reported the device experienced pinch/crush point.No adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
An additional event was identified and therefore added to this summary report.
Event or Problem Description
This report now summarizes 2 malfunction events, instead of 1.
Event or Problem Description
This report now summarizes 4 malfunction events, instead of 2.It was further reported that there were 4 minor injuries.
Additional Manufacturer Narrative
2 devices that were pending evaluation were not made available by the customer; the reported issue was not confirmed.2 additional events were identified and therefore added to this summary report.

• Brand Name: MV3
• Common Device Name: BARIATRIC BED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 21919976
• Report Number: 0001831750-2025-00574
• Device Sequence Number: 15711179
• Product Code: OSI
• UDI-Device Identifier: 07613327419221
• UDI-Public: 07613327419221
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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 Catalogue Number: 5900000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 04/01/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/02/2025; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown