MAUDE Adverse Event Report: JOERNS HEALTHCARE ECSBED; PATIENT BED

Model Number ECSBED

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 02/27/2023

Event Type  malfunction  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that while houskeeping was cleaning the bed, the headend fell while she was underneath.Plastic sleeve that connects to the hydraulic broke.Bed fell on top of her, pinning her between the bed and the floor.Complaint #(b)(4) were entered into our system to have the product returned for investigation.As of this writing, the product has not been returned.

Manufacturer Narrative

This report or other informtion submitted by joerns healthcare under 21 cfr part 803, and and 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.

• Brand Name: ECSBED
• Type of Device: PATIENT BED
• 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: 16618556
• MDR Text Key: 312100709
• Report Number: 3009402404-2023-00012
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2023

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?: Yes
• Device Operator: Other
• Device Model Number: ECSBED
• Device Catalogue Number: ECSBED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/27/2023
• 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): Other
• Patient Sex: Female