MAUDE Adverse Event Report: JOERNS HEALTHCARE ULTRACARE BED; PATIENT BED

Model Number U770

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 12/08/2019

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.(b)(4).

Event Description

It was reported to the manufacturer by the end user, per the end user, there was a wastepaper basket under the bed and the bed was lowered onto the wastepaper basket.Once the wastepaper basket gave under the weight of the bed, the bed dropped to the floor (about 1'-1.5').This caused the patient to sustain a neck injury and patient was sent to the hospital for evaluation.The bed was evaluated on 12/9/2019 by facility maintenance, was determined to be in good working order and returned to service.Complaint# (b)(4) was entered into our system.

• Brand Name: ULTRACARE BED
• Type of Device: 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: 9583316
• MDR Text Key: 175050080
• Report Number: 3009402404-2020-00005
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: U770
• Device Catalogue Number: U770
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/27/2019
• 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): Hospitalization
• Patient Weight: 83