MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BED INTOUCH WITH ZOOM MOTOR; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number	2141000000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.12 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.2 devices were not evaluated and no cause was determined, as the customers did not make the devices accessible for testing.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 15 malfunction events, where it was reported the devices experienced reduced/inadequate brake force.No adverse consequence or clinically relevant delay in treatment was reported.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
In accordance with the ¿final guidance on medical device reporting for manufacturers¿ issued on november 7, 2016, stryker medical will no longer report the hazard of reduced/inadequate brake force for our bed lines (product code fnl), as this hazard has not caused or contributed to any serious injuries in at least two years.The last serious adverse event manufacturer report #0001831750-2019-00271 was originally submitted on february 21st, 2019.While no new mdrs will be generated for this hazard moving forward, additional supplemental records may be submitted for past reported events if new information becomes available.Should a new serious adverse event occur attributed to this hazard, mdr reporting will resume.
Additional Manufacturer Narrative
The device that was pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Evaluation results findings (components/results).1 device: caster/mechanical problem identified.
Event or Problem Description
No new information.

• Brand Name: BED INTOUCH WITH ZOOM MOTOR
• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 22576194
• Report Number: 0001831750-2025-99069
• Device Sequence Number: 13186781
• Product Code: FNL
• UDI-Device Identifier: 07613327169232
• UDI-Public: 7613327169232
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 15
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2025

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: 2141000000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 07/01/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/01/2025; 10/27/2025
• 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