MAUDE Adverse Event Report: STRYKER CORPORATION S3; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 3005

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problems Fall (1848); Head Injury (1879); Laceration(s) (1946)

Event Date 03/25/2023

Event Type  malfunction  

Event Description

Bed malfunction, bed alarm not sounding.In this case the patient fell, no alarm sounded due to bed malfunction, and the patient sustained a reportable injury (head laceration requiring sutures).

• Brand Name: S3
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER CORPORATION; 3800 e. centre ave; portage MI 49002
• MDR Report Key: 16753101
• MDR Text Key: 313429803
• Report Number: 16753101
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3005
• Device Catalogue Number: 3005S3EX
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Sex: Female
• Patient Race: White