MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PROCUITY ZX WITH ISOTOUR PREM; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number	3009PX-ZX-450
Medical Device Problem Codes	No Audible Alarm (1019); Mechanical Problem (1384)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the alarm was not going off/bed alarm malfunctioning on a patient's bed.It was further reported that the patient fell and hit his head on the floor, resulting in a transfer to the ccu/icu.
Additional Manufacturer Narrative
It was reported to a stryker sales account manager at the customer site that allegedly a patient fell as the bed exit alarm was not triggered on the patient's bed.Furthermore, it was reported that allegedly the bed locked up while pushing the patient to another unit.The correct serial number and device were identified.A visual and functional inspection was performed by a stryker field service technician.It was found that the bed exit alarm system was operating properly, and there were no component level defects of the product.In addition, the stryker sr.Qae spoke to the stryker sales account manager who provided that the customer confirmed the patient did not experience any injury from the fall.Additionally, he provided that the customer was able to move the bed after the alleged brakes engaged inadvertently.Based on this, the stryker sr.Qae determined that the alleged brakes unexpectedly engaged was likely not due to any component level defects of the product.The issue was resolved for the customer by evaluating the bed and returning the unit to service.
Event or Problem Description
It was reported that the alarm was not going off/bed alarm malfunctioning on a patient's bed.It was further reported that the patient fell and hit his head on the floor, resulting in a transfer to the ccu/icu.

• Brand Name: PROCUITY ZX WITH ISOTOUR PREM
• 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19410305
• Report Number: 0001831750-2024-00703
• Device Sequence Number: 8507265
• Product Code: FNL
• UDI-Device Identifier: 07613327541366
• UDI-Public: (01)07613327541366
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 3009PX-ZX-450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown