MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 PX4-3005; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 3005S3PX4

Device Problem No Audible Alarm (1019)

Patient Problems Fall (1848); Insufficient Information (4580)

Event Date 12/15/2023

Event Type  Death  

Manufacturer Narrative

The unit was evaluated by a stryker field service technician.He tested all three zones of the bed exit with the nurse present and was unable to duplicate the issue.Based on this information, it was determined that the bed exit alarm not sounding was most likely due to it not being set correctly, not any component level defect or malfunction.After further communication with the user facility, it was not certain that the bed exit alarm had been turned on.A stryker quality assurance engineer spoke with a nurse at the account who explained that the patient died at the time of the fall.It is unknown if the patient¿s death was a result of the fall or a medical event.The issue was resolved by confirming no further action was needed by stryker at this time.

Event Description

It was reported that the device's bed alarm did not sound.As a result, a patient fell out of bed.The patient passed away.It is unknown if this was a result of the fall or a separate medical event.

• Brand Name: S3 PX4-3005
• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18916532
• MDR Text Key: 337811323
• Report Number: 0001831750-2024-00328
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327278422
• UDI-Public: 07613327278422
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 3005S3PX4
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• 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): Death