MAUDE Adverse Event Report: JOERNS HEALTHCARE EASY CARE BED; ELECTRIC PATIENT BED

Model Number B684DC

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 12/23/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported to the manufacturer by the end user, per the end user patient fell out of bed.The bed in question was found tipped over on its side next to the patient.The facility is not clear if the patient fell out of the bed when the bed tipped over or if the bed was pulled over when the patient was on the floor.The patient was sent to the er for evaluation.The patient sustained multiple bruises, skin tears and a chipped tooth.(b)(4) were entered into our system to have the bed returned to joerns for investigation.As of this writing, the bed has not been returned.

• Brand Name: EASY CARE BED
• Type of Device: ELECTRIC PATIENT BED
• Manufacturer (Section D): JOERNS HEALTHCARE; 5001 joerns drive; stevens point WI 54481
• Manufacturer (Section G): JOERNS HEALTHCARE; 5001 joerns drive; stevens point WI 54481
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 5370520
• MDR Text Key: 36092862
• Report Number: 3009402404-2016-00001
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B684DC
• Device Catalogue Number: ECSBED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2015
• Initial Date FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization
• Patient Age: 90 YR
• Patient Weight: 82