MAUDE Adverse Event Report: JOERNS HEALTHCARE ARISE LAL; PATIENT AIR MATTRESS

Model Number AREXLAL-4888NZ

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 01/26/2023

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 veteran called joerns regarding his arise 1000 ex mattress (he said it's on an acx bed).He's a resident at the nursing home and received the bed about a month ago.A week or so after that, the bed mayhave leaked because his rear end started hurting.He inserted 3 inch foam which alleviated the issue but the nursing home staff removed it.It took about one month to get permission from the kc veterans medical center to send a tech.Doctors equipment service (816-523-6644) dispatched and worked with joerns product support and made adjustments but problem remains.It feels like something is sticking him.Complaint #(b)(4) was entered into our system.

• Brand Name: ARISE LAL
• Type of Device: PATIENT AIR MATTRESS
• 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 ; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• MDR Report Key: 16454134
• MDR Text Key: 310363151
• Report Number: 3009402404-2023-00004
• Device Sequence Number: 1
• Product Code: FNM
• 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: 02/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AREXLAL-4888NZ
• Device Catalogue Number: AREXLAL-4888NZ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2023
• 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: Male