MAUDE Adverse Event Report: JOERNS HEALTHCARE EASYCARE BED; PATIENT ELECTRIC BED

Model Number ECSBED

Device Problems Device Maintenance Issue (1379); Material Separation (1562)

Patient Problem Injury (2348)

Event Date 03/09/2017

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, patient sustained a skin tear to the lower right leg from the bed.Complaint# (b)(4) was entered into our system.

• Brand Name: EASYCARE BED
• Type of Device: PATIENT ELECTRIC 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: 6914254
• MDR Text Key: 88169664
• Report Number: 3009402404-2017-00047
• 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: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ECSBED
• Device Catalogue Number: ECSBED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2017
• 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): Other