MAUDE Adverse Event Report:; HOSPITAL ELECTRIC BED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 09/13/2018

Event Type  Injury  

Event Description

Pt fell (unwitnessed) out of bed in nursing home.Pt had just received wound care in bed and nurse had asked cna to change her briefs.When cna went into room, pt was found on floor with large amount of blood around her.Hme was notified of event and mfr is unk.The bed is the property of the facility where pt resides.

• Type of Device: HOSPITAL ELECTRIC BED
• MDR Report Key: 8096854
• MDR Text Key: 128211005
• Report Number: 8096854
• 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: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2018
• Distributor Facility Aware Date: 09/13/2018
• Event Location: Nursing Home
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 94 YR
• Patient Weight: 59