MAUDE Adverse Event Report: PROBED MEDICAL TECHNOLOGIES, INC. FREEDOM BED; BED, PATIENT ROTATION, POWERED

Device Problems Pressure Problem (3012); Sharp Edges (4013); Intermittent Energy Output (4025)

Patient Problem Pain (1994)

Event Date 07/27/2021

Event Type  Injury  

Event Description

I am a resident in a (b)(6) living center.The air mattress circulated to the areas of least resistance causing sharp edges of the air pockets to ¿elevate¿ and press on the scrotal and anal areas, causing severe pain.On numerous occasions, when the bed computer failed to function properly, the air mattress would simply collapse leaving me on the hard metal frame, causing severe lumbar pain.On other occasions, the air mattress would inflate so much that my knees would be trapped under the overbed table, and the mattress would push my knees against the overbed table trying to lift it causing severe knee pain.My left knee was x-rayed and showed no fracture, but the pain was intense.I required ice packs and a topical analgesic cream for some relief.These events caused me severe new and additional pain that i had not previously experience due to my on-going disabilities.

• Brand Name: FREEDOM BED
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): PROBED MEDICAL TECHNOLOGIES, INC.
• MDR Report Key: 14958185
• MDR Text Key: 295671556
• Report Number: MW5110759
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: CURRENT PRESCRIPTION MEDICATIONS: CALCIUM; CURRENT PRESCRIPTION MEDICATIONS: DAILY VITAMIN.; CURRENT PRESCRIPTION MEDICATIONS: GABAPENTIN.; CURRENT PRESCRIPTION MEDICATIONS: INSULIN ASPARTANE.; CURRENT PRESCRIPTION MEDICATIONS: INSULIN LANTUS.; CURRENT PRESCRIPTION MEDICATIONS: OTHER MEDICATIONS BEING DISPENSED BY CLC NURSE.; CURRENT PRESCRIPTION MEDICATIONS: TYLENOL.
• Patient Outcome(s): Other; Disability
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 91 KG