MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PROCUITY ZMX WITH ISOLIBRIUM; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number	3009PX-ZMX-600
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 43 malfunction events(s), where it was reported the devices experienced unintended direction of the zoom.No adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was functionally/visually inspected in the field.The device was repaired and returned to use.42 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
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 un-commanded (¿phantom¿) motion of the electronic bed positioning functions (not for zoom) 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 #0001831750-2018-01101 was originally submitted on october 18th, 2018.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.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The 42 devices that were pending was found after communication with the account that the customer was frustrated with the amount of time they need to wait to push the devices after putting them in the neutral brake/drive position.Additionally, the customer was dissatisfied with the battery life of the devices.These are both customer preference issues and there are no malfunctions with the devices.
Event or Problem Description
This report now summarizes 1 malfunction event(s), instead of 43.

• Brand Name: PROCUITY ZMX WITH ISOLIBRIUM
• 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: 22578957
• Report Number: 0001831750-2025-99126
• Device Sequence Number: 13098250
• Product Code: FNL
• UDI-Device Identifier: 07613327541328
• UDI-Public: 7613327541328
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 1
• 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): 10/24/2025

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: 3009PX-ZMX-600
• 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; 10/24/2025
• 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