MAUDE Adverse Event Report: JOERNS HEALTHCARE JOERNS B530 BED; ELECTRIC PATIENT BED

Model Number B530

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Physical Entrapment (2327)

Event Date 01/21/2017

Event Type  Death  

Manufacturer Narrative

Additional equipment involved: bilateral half side rails were installed on the bed.Brand name nor model number have been provided.

Event Description

It was reported to the manufacturer by the end user, per the end user, "patient was found unresponsive at approximately 2:20 a.M.With his head trapped between the mattress and side rail of his bed.The coroner declared patients' cause of death as asphyxia caused by neck compression that occurred when his head was trapped between the mattress and side rail.The mattress provided to the facility did not fit the bed, leaving gaps between the mattress and bed rails." complaint# (b)(4) was entered into our system.

• Brand Name: JOERNS B530 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: 7872241
• MDR Text Key: 120108960
• Report Number: 3009402404-2018-00059
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B530
• Device Catalogue Number: B530
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2018
• 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): Death
• Patient Age: 63 YR
• Patient Weight: 70