MAUDE Adverse Event Report: Stryker Medical-Kalamazoo INTOUCH ZOOM MTS PREV PCK; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number	2141PX2000
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Malfunction

• Brand Name: INTOUCH ZOOM MTS PREV PCK
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; +1(269)329-2100
• MDR Report Key: 50045802
• Report Number: 0001831750-2026-99361
• Device Sequence Number: 10539690
• Product Code: FNL
• UDI-Device Identifier: 07613327385427
• UDI-Public: 07613327385427
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: 2141PX2000
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• 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