MAUDE Adverse Event Report: JOERNS HEALTHCARE ARISE 1000 EX MATTRESS; PATIENT AIR MATTRESS

Model Number AREXLAL-4888-M

Device Problem Device Operational Issue (2914)

Patient Problem Fall (1848)

Event Date 05/04/2018

Event Type  malfunction  

Event Description

It was reported to the manufacturer by the end user, per the end user, "the equipment deflated and patient fell out the bed".The patient was sore and has bruising on the right hip and shoulder.(b)(4) were entered into our system to have the mattress and control unit returned to joerns for investigation.As of this writing, the mattress and control unit have not been returned.

• Brand Name: ARISE 1000 EX MATTRESS
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 7510310
• MDR Text Key: 108156156
• Report Number: 3009402404-2018-00027
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/11/2018

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: Health Professional
• Device Model Number: AREXLAL-4888-M
• Device Catalogue Number: AREXLAL-4888-M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2018
• Initial Date FDA Received: 05/14/2018
• 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 Age: 73 YR
• Patient Weight: 159