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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY PRODUCTS EUROPEAN POSEY BED 8080; PATIENT BED WITH CANOPY/RESTRAINTS
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POSEY PRODUCTS EUROPEAN POSEY BED 8080; PATIENT BED WITH CANOPY/RESTRAINTS Back to Search Results
Model Number 8080
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Physical Entrapment (2327)
Event Date 01/18/2022
Event Type  Death  
Event Description
As reported by mdss, (b)(6) a nursing home in the (b)(6) , reported that on (b)(6) 2022, a (b)(6) year old resident was found lifeless in the posey canopy.It is reported that the resident was bent over, with her head towards the foot end of the bed, with her head against the side, and with the mattress half on her face.She lay in a prone position.There were no blankets on her face.The posey canopy was closed and was on the brake.The coroner and doctor concluded there was a suspicion of suffocation.
 
Manufacturer Narrative
Device evaluated by mfr: the customer had 7 posey beds that were rented from 2015 until 2016.In 2016, the beds were purchased by the nursing home institution, (b)(6).The beds have not been serviced or trained on by the distributor, (b)(4), since purchase in 2016.When (b)(4) went to the nursing home to investigate in response to the bed death report, they found the beds in significant filth and disrepair.The bed related to this death contained an extraneous mattress implicated in the suffocation.The posey bed 8080 is a hospital bed, canopy, and mattress system designed to help provide a safe, controlled environment for patients at extreme risk of injury from a fall or unassisted bed exit.The posey bed is a passive alternative to direct restraints such as belts, vests, or jackets for adult and pediatric patients at least 117 centimeters tall, weighing between 21 and 136 kilograms.However, it is still a restraint, and must be prescribed by a licensed physician, rx only, or the authority legally allowed to prescribe restricted medical products, and must only be used under the direct supervision and authority of the medical team.The instructions for use as indicated in the user manual document (b)(4) , was reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu has numerous warnings to reduce the risk of serious injury or death.These warnings include always using hospital bed safety workgroup (hbsw) compliant side rails in the up position and to fill all gaps to reduce the risk of entrapment, and using side rail covers and gap protectors to help prevent the patient's body from going under, around, through or between the side rails.Never put a mattress inside the patient area.Doing so may allow the patient to crawl under the mattress and suffocate.The mattress must be fully zippered into the mattress compartment at all times.Patients should be monitored per facility policy to ensure that the patient cannot slide down or fall off the mattress and become suspended or entrapped.Use of the device should be stopped at once if the patient is at risk to slide forward or down in the device.Before leaving the patient unattended, caregivers are instructed to explain the use of the device to the patient and ensure that the patient understands how to self-release in case of emergency.The bed canopy was not returned for evaluation and remains in use at the nursing home facility.Therefore, this report is based on the information provided by the distributor (b)(4).Additional information received by the distributor's investigation noted that the canopy was found at the nursing home facility with damage.The canopy contained a non-approved mattress inside the patient area, which is a contraindication for the instructions for use.Therefore, based on the information currently available, there is no indication that the device malfunctioned but was misused by the nursing home facility by adding an extraneous mattress to the patient compartment.Image retained and available upon request.At this time there is no evidence that a manufacturing nonconformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Although no corrective or preventative actions are necessary at this time by the manufacturer, re-training of the staff on proper usage was conducted by a human protection representative.(b)(4) manufacturer reference file (b)(4).(b)(4).Product not being returned.
 
Manufacturer Narrative
Device evaluated by mfr: the customer had 7 posey beds that were rented from 2015 until 2016.In 2016, the beds were purchased by the nursing home institution, (b)(6).The beds have not been serviced or trained on by the distributor, (b)(4), since purchase in 2016.When (b)(4) went to the nursing home to investigate in response to the bed death report, they found the beds in significant filth and disrepair.The bed related to this death contained an extraneous mattress implicated in the suffocation.The posey bed 8080 is a hospital bed, canopy, and mattress system designed to help provide a safe, controlled environment for patients at extreme risk of injury from a fall or unassisted bed exit.The posey bed is a passive alternative to direct restraints such as belts, vests, or jackets for adult and pediatric patients at least 117 centimeters tall, weighing between 21 and 136 kilograms.However, it is still a restraint, and must be prescribed by a licensed physician, rx only, or the authority legally allowed to prescribe restricted medical products, and must only be used under the direct supervision and authority of the medical team.The instructions for use as indicated in the user manual document (b)(4) , was reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu has numerous warnings to reduce the risk of serious injury or death.These warnings include always using hospital bed safety workgroup (hbsw) compliant side rails in the up position and to fill all gaps to reduce the risk of entrapment, and using side rail covers and gap protectors to help prevent the patient's body from going under, around, through or between the side rails.Never put a mattress inside the patient area.Doing so may allow the patient to crawl under the mattress and suffocate.The mattress must be fully zippered into the mattress compartment at all times.Patients should be monitored per facility policy to ensure that the patient cannot slide down or fall off the mattress and become suspended or entrapped.Use of the device should be stopped at once if the patient is at risk to slide forward or down in the device.Before leaving the patient unattended, caregivers are instructed to explain the use of the device to the patient and ensure that the patient understands how to self-release in case of emergency.The bed canopy was not returned for evaluation and remains in use at the nursing home facility.Therefore, this report is based on the information provided by the distributor (b)(4).Additional information received by the distributor's investigation noted that the canopy was found at the nursing home facility with damage.The canopy contained a non-approved mattress inside the patient area, which is a contraindication for the instructions for use.Therefore, based on the information currently available, there is no indication that the device malfunctioned but was misused by the nursing home facility by adding an extraneous mattress to the patient compartment.Image retained and available upon request.At this time there is no evidence that a manufacturing nonconformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Although no corrective or preventative actions are necessary at this time by the manufacturer, re-training of the staff on proper usage was conducted by a (b)(4) representative.(b)(4).Product not being returned.
 
Event Description
As reported by mdss, (b)(6) a nursing home in the (b)(6) , reported that on (b)(6) 2022, a (b)(6) year old resident was found lifeless in the posey canopy.It is reported that the resident was bent over, with her head towards the foot end of the bed, with her head against the side, and with the mattress half on her face.She lay in a prone position.There were no blankets on her face.The posey canopy was closed and was on the brake.The coroner and doctor concluded there was a suspicion of suffocation.
 
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Brand Name
EUROPEAN POSEY BED 8080
Type of Device
PATIENT BED WITH CANOPY/RESTRAINTS
Manufacturer (Section D)
POSEY PRODUCTS
2530 lindsay privado drive
unit a
ontario CA 91761
Manufacturer Contact
chris rahn
570 enterprise dr
neenah, WI 54956
9207514300
MDR Report Key13604752
MDR Text Key286238381
Report Number2020362-2022-00008
Device Sequence Number1
Product Code OYS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 01/26/2022
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 Health Professional
Device Model Number8080
Device Catalogue Number8080
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/26/2022
Initial Date FDA Received02/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
Patient SexFemale
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