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

Model Number P11P090L0_0SGWT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 02/07/2023

Event Type  Injury  

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.

Event Description

It was reported to the manufacturer, by the end user, per the end user, that at 2:38 pm on (b)(6) 2023, pi called to report an incident that allegedly involved the following product or device: bed - panacea 1000.Pi reported that the following occurred: resident had been pulling on the bed and the handlrails themselves, he had pulled on it so much with the extension on there, he had bent it to the point where pins came out, he fell out of bed and injured himself.Pi reported that the injured party was hospitalized.It is unknown how many people were present during the incident.When asked about an ideal outcome, pi said: customer would first request paperwork for state report regarding weight capacity of bed/ width extensions, did not inquire about warranty at this time.I said that we would discuss with the supplier and follow up with the facility 24 from receipt of photos.Complaint #(b)(4).Was entered into our system to have the products returned for investigation.As of this writing, the products have not been returned.

• Brand Name: PANACEA 1000 BED
• 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: 16519405
• MDR Text Key: 311037253
• Report Number: 3009402404-2023-00006
• 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
• Type of Report: Initial
• Report Date: 03/08/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: P11P090L0_0SGWT
• Device Catalogue Number: P11P090L0_0SGWT
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/09/2023
• 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; Hospitalization
• Patient Sex: Male