MAUDE Adverse Event Report: JOERNS HEALTHCARE BARI10A BARIATRIC BED; BARIATRIC ELECTRIC PATIENT BED

Model Number BARI10ABED

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

Patient Problem Injury (2348)

Event Date 04/20/2016

Event Type  Injury  

Manufacturer Narrative

Numerous requests to this facility have been made to receive additional information and details related to this alleged incident report with no response from the facility.

Event Description

It was reported to the manufacturer by the end user, per the end user a nurse was extending the width of a bariatric 10a by 6in and the nurse accidentally grabbed the purple lever underneath the bed to do so and it smacked her in the face.It was also reported that the nurse took time off because of this incident.At this time, the injuries are unknown.Numerous requests to this facility have been made to receive additional information and details related to this alleged incident report with no response from the facility.Complaint#(b)(4) was entered into our system.

• Brand Name: BARI10A BARIATRIC BED
• Type of Device: BARIATRIC ELECTRIC PATIENT BED
• Manufacturer (Section D): JOERNS HEALTHCARE; 2100 design road; arlington TX 76014
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 5700079
• MDR Text Key: 46560976
• Report Number: 3009402404-2016-00022
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BARI10ABED
• Device Catalogue Number: BARI10ABED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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