MAUDE Adverse Event Report: JOERNS HEALTHCARE PANACEA 1000; PATIENT BED

Model Number	PAN1000-FLEX-RIL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report or other information submitted by joerns healthcare under 21 cfr part 803, 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.
Event or Problem Description
It was reported to the manufacturer, by the end user, per the end user, that (b)(6) forwarded an email from (b)(6)"at 2:30 pm on (b)(6) 2025, (b)(6) called to report an incident that allegedly involved the following product or device: bed.(b)(6) reported that the following occurred at last night on (b)(6) 2025: customer reported the foot end of the bed dropped quickly with a resident in it.(no injury tho).Our maintenance team replaced the bed and then inspected the issue.The shaft in the motor that raises and lowers the foot of the end of the bed broke.There were no injuries according to (b)(6).The product has been taken out of use.The resident's weight is customer did not give a weight but said the one item that was checked first was the safe working load is listed at 450lbs and the resident is well under that, so that should not be a factor in the problem.(b)(6).Complaint#: (b)(4) and ra#: 84096615 were entered into our system to have the bed returned for investigation.As of this writing, the bed has not been returned.

• Brand Name: PANACEA 1000
• Common Device Name: 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: 21429285
• Report Number: 3009402404-2025-00005
• Device Sequence Number: 11846421
• Product Code: FNL
• UDI-Device Identifier: 00810055883066
• UDI-Public: 00810055883066
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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?: No
• Device Model Number: PAN1000-FLEX-RIL
• Device Catalogue Number: PAN1000-FLEX-RIL
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Congenital Anomaly
• Patient Sex: Female