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

Model Number BARI10A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

This report or other information submitted by joerns healthcare under 21 cfr part 803, and any release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare, its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.

Event Description

It was reported to the manufacturer, by the end user, per the end user, the patient fell off the bari 10-a bed that was being used.Patient is confused and high fall risk.Patient was put in new bed and staff realized there was no bed alarm.Complaint # (b)(4) was entered into our system.

• Brand Name: BARI10A
• Type of Device: BARIATRIC BED, PATIENT
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: mackenzie bay ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 11632365
• MDR Text Key: 250237748
• Report Number: 3009402404-2021-00003
• Device Sequence Number: 1
• Product Code: OSI
• 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: Other
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BARI10A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2021
• 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): Required Intervention