MAUDE Adverse Event Report: GENADYNE BIOTECHNOLOGIES, INC. GENADYNE MNS 600 ACCUTURN MATTRESS SYSTEM; MNS 600 THERAPEUTIC MATTRESS SYSTEM

Model Number 6-1008-184

Device Problem Device Issue (2379)

Patient Problem Death (1802)

Event Date 07/09/2015

Event Type  Death  

Manufacturer Narrative

The patient involved was reported to be deceased without further details, therefore this report is being submitted as "death" related as a cautionary measure.Genadyne is not assuming responsibility for the patient death as it is unclear the reason for death.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.Genadyne did not immediately notify the fda of this reportable event due to a pending litigation for which all parties had a privileged settlement discussion enforced and then an nda.

Event Description

This information was received on 07/16/2015.Patient (b)(6) was severely debilitated due to a car accident in 2010.As a result, she was incapacitated and was prescribed a turning/repositioning air mattress system called the genadyne mns 600 accuturn mattress system.The genadyne accuturn system combines pressure relief, micro low air loss, with lateral rotation to promote circulation and accelerate healing while reducing complications of patient immobility (ie: decubitus ulcers, nosocomial pneumonia, circulatory problems, urinary tract infections, etc.) for the homebound and hospitalized patient.The mattress is designed to accommodate all standard hospital beds and can be customized for bariatric patients as well as any size, home bed frame.The genadyne mns 600 is a full depth (8") lateral turning mattress replacement system which reduces interface pressure for the treatment of stage i through stage iv pressure ulcers.The mns 600's powerful, lightweight, and easy-to transport power unit inflates the mattress in less than 5 minutes.Caregiver-friendly controls and several valuable user functions - including auto-firm, cpr deflate and simplified patient weight settings - further enhance the mns 600's advanced therapeutic performance.The genadyne mattress system was attached directly to a hospital bed manufactured and maintained by invacare corporation: model 5490ivc.The specific genadyne mattress at issue was prescribed by the patient's doctor and was delivered to the patient in 2013.Sometime after delivery of the prescription-only mattress, the patient and her mother moved to another home.They did not notify genadyne of the move, so it was not installed by genadyne onto the invacare bed.At some point, the invacare bed broke (structurally) and was never fixed.Nevertheless, the patient continued to use the unrepaired invacare bed.The genadyne mattress's integrity is dependent upon proper and safe installation on the invacare bed.At no time did the patient's mother notify genadyne of the invacare bed's physical translocation or broken condition.Meanwhile, the patient improved medically and became able to turn over on her own.Once she was able to turn over, the undulating mattress system became contraindicated for her condition.However, to the best of genadyne's knowledge, her health care providers did not change the patient's prescription to a mattress for the hospital bed that is suited for an individual who can turn themselves, nor did the patient's mother make any inquiry with genadyne as to its continued use since the patient could turn herself.The police report created on the day of the event states that the mattress had deflated completely, the patient was face down on the corner, and the pump was not on.Based on pictures, the power plug appears to be connected.According to the medical examiner's autopsy report, cause of death was "positional asphyxia" that occurred by a "disabled woman sleeping prone in deflated hospital bed." upon investigation, it appears that the victim's gross negligence of adhering to the maintenance schedule of the mattress system led to the alleged failure of the genadyne mattress.

• Brand Name: GENADYNE MNS 600 ACCUTURN MATTRESS SYSTEM
• Type of Device: MNS 600 THERAPEUTIC MATTRESS SYSTEM
• Manufacturer (Section D): GENADYNE BIOTECHNOLOGIES, INC.; 16 midland ave; hicksville NY 11801
• Manufacturer (Section G): GENADYNE BIOTECHNOLOGIES, INC; 16 midland ave; hicksville NY 11801
• Manufacturer Contact: andrew goh ; 16 midland ave; hicksville, NY 11801 ; 5164878787
• MDR Report Key: 7314386
• MDR Text Key: 101559432
• Report Number: 3011582224-2018-00003
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CL II EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2018

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?: No
• Device Operator: Patient Family Member or Friend
• Device Model Number: 6-1008-184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 5 YR
• Event Location: Home
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 25 YR
• Patient Weight: 45