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

Model Number 300900000000

Device Problem No Audible Alarm (1019)

Patient Problem Fall (1848)

Event Date 11/28/2022

Event Type  malfunction  

Event Description

It was reported that the device's brakes are being turned off unknowingly by the patients via a button on the handrails.It was further reported that there was a bad fall due to the alarm not being activated.Attempts are being made to gather additional injury and treatment details from the user facility.

Event Description

It was reported that the device's brakes are being turned off unknowingly by the patients via a button on the handrails.It was further reported that there was a fall due to the alarm not being activated.There were no adverse consequences reported.

Manufacturer Narrative

It was confirmed that the unit did not require evaluation from stryker field service as this was likely user error.

• Brand Name: PROCUITY BED
• Type of Device: 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 millard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16024109
• MDR Text Key: 305906939
• Report Number: 0001831750-2022-01234
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327512656
• UDI-Public: 07613327512656
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 300900000000
• Device Catalogue Number: 300900000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other