MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD. ROSCOE; FULL LENGTH BED RAILS

Model Number PB6034

Device Problem Use of Device Problem (1670)

Patient Problem Strangulation (2084)

Event Date 10/04/2022

Event Type  Death  

Event Description

Epidemiologic investigation report: while in home hospice case, a 66yr old female slid off a hospital bed mattress onto a bar supporting the rail of the bed.The cause of death was positional asphyxia.Incident summary: on (b)(6) 2022 the victim moved from louisiana to kentucky to be cared for by her friend.The victim was a paraplegic who was receiving hospice home care.At that time she became a client of the hospice home care provider.On (b)(6) 2022 the victim received the incident bed, rails & mattress from the hospice care provider.On (b)(6) 2022 the victim reportedly went to sleep at 1:00am.According to official reports, the caregiver advised that the victim usually slept until 12:00pm but she called at 11:00am.When the victim didn't answer the phone the caregiver checked on her.That is when she found her lying on the side of the bed, blue.Hospice advised that the victim was found between the bed mattress and the support for the exterior rail.They stated she had limited movement of her upper torso but was able to turn over in bed.She was being treated for an ulcer on her back at the time of death.The cause of death was positional asphyxia.The manner of death was accidental.Lexington division of fire & ems patient care record: ems dispatched for unresponsive.Crew finds patient laying in hospital bed at home.Patient is unresponsive, apneic, pulseless, asystole in 2 contiguous leads, pupils fixed/dilated with rigor mortis and lividity.Caretaker on the scene state the patient was a family friend and she was taking care of her because she had no one else to care for her.The patients dnr is also present for the crew to witness.Caretaker states the patient was last seen alive 10hrs ago at 1:00am this morning.Caretaker states the patient had multiple health issues and has been a hospice patient for the past 2 months now.Crew pronounces the patient deceased.Scene turned over to hospice staff.Fayette county coroners office report: approx 1100hrs she advised the decedent normally sleeps until 12 but the aids to bathe her had called at 11am and advised they were on their way.She called for ems when she found her lying on the side of the bed and was blue.No consent was provided for the release of the victims name or contact information and their identity is to remain confidential.Per the assistant records custodian at the lexington police dept: the only documentation i was able to locate is a dispatch log.No report was made and no photographs were taken.Per item warning for the device that was provided by the cpsc report; a copy of the user manual.Warnings assembly, installation and operating instructions save these instructions model no.Pb6034 for more information regarding compass products, parts, and services, please visit www.Compasshealthbrands.Com.Do not install or use this equipment without first reading and understanding these instructions.If you are unable to understand the warnings, cautions or instructions, contact a healthcare professional, dealer or technical personnel before attempting to install this equipment - otherwise, death, injury or property damage may occur.These bed rails are intended to prevent an individual from inadvertently rolling out of bed.Do not use for restraint purposes.Entrapment may occur.Proper patient assessment and monitoring, and proper maintenance and use of equipment is required to reduce the risk of entrapment.Variations in bed rail dimensions, and mattress thickness, size or density could increase the risk of entrapment.Visit the fda website at http://www.Fda.Gov to learn about the risks of entrapment.Compass products are specifically designed and manufactured for use in conjunction with compass accessories.Accessories designed by other manufacturers have not been tested by compass and are not recommended for use with compass products.To reduce the risk of entrapment make certain that the cross braces do not exceed the width of the mattress.Mattress must fit bed frame and side bed rails snugly to reduce the risk of entrapment.

• Brand Name: ROSCOE
• Type of Device: FULL LENGTH BED RAILS
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD.; no.61 & no.96, zhaoyi road, do; zhongshan city guangdong, 52841 4; CH 528414
• MDR Report Key: 18720140
• MDR Text Key: 335566507
• Report Number: 3012316249-2024-00003
• Device Sequence Number: 1
• Product Code: QTC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PB6034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2024
• Distributor Facility Aware Date: 01/22/2024
• Event Location: Home
• Date Report to Manufacturer: 02/16/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROACTIVE PROTEKT AIRE 4000DX LOW AIRLOSS MATTRESS; PROBASICS FULL ELECTRIC BED, ITEM PBFEB3MLO
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Sex: Female