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

Device Problem Defective Component (2292)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/28/2022

Event Type  Injury  

Event Description

Stryker bed fell when cna raised the bed with the patient in it.Patient complained of back pain.X-ray ordered and revealed right scapular hairline fracture.Bed was inspected by arjo on (b)(6) 2022.Per inspection report, motor for head hi/lo support bracket failed causing bed to fall.It appears to be a fresh break and not a ongoing issue.Bed is not repairable.Fda safety report id# (b)(4).

• Brand Name: STRYKER LUS-OEMOTHER BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL
• MDR Report Key: 15192781
• MDR Text Key: 297609931
• Report Number: MW5111351
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female