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

Model Number 3009PX

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 08/26/2023

Event Type  malfunction  

Event Description

Bed alarm had been set to "on" when patient care technician's (pct) rounding on patient.Alarm did not sound when patient got out of bed.Patient slipped and fell on floor.Patient suffered harm with a small skin tear to right forearm that did not require treatment.Bed control panel found to be "black" and not functioning.Bed taken out of service, and patient placed on new bed.Biomed tested this bed afterwards, found to be fully functional and alarm settings working as intended.

• Brand Name: PROCUITY
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre ave; portage MI 49002
• MDR Report Key: 17772414
• MDR Text Key: 323697701
• Report Number: 17772414
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3009PX
• Device Catalogue Number: 3009PX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2023
• Date Report to Manufacturer: 09/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33215 DA