MAUDE Adverse Event Report: J.T. POSEY COMPANY POSEY BED 8070; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number 8070

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fracture, Arm (2351)

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested but has not yet been received.Note; this submission is based solely on the user facility's reported issue.Note: the instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Specifically checking the zipper, the ifu warn users to, "never leave the patients bedside until all access panel zippers are completely closed.Quick-release buckles be connected and closed on all four access panels before the patient is left alone." (b)(4).No alleged malfunction.

Event Description

Customer mentioned that a patient fell out of the canopy and fractured their elbow.Customer was unable to provide any other information.Customer requested a sign that reminds staff to make sure that the canopy window is zipped closed.The exact date of event is unknown.

Manufacturer Narrative

Customer provided additional information regarding the incident occurring during a shift change.The patient had both a sitter and respiratory therapist.The respiratory therapist turned their back to obtain medication, when the patient rolled towards the floor, falling on their side and landing on their elbow.The enclosure was not been zipped up, allowing the patient to be able to fall out.The patient's injury was reported as "soft tissue swelling at the olecranon process and proximal medial forearm.A subtle linear density was seen paralleling the cortex of the olecranon process and may represent small chip fx." the unit director was contacted regarding the patients outcome.Unit director confirmed, "no surgery was indicated and was discharged to a skilled nursing facility (snf).The cause of the fall was not from a manufacturing standpoint or device failure." at this time, due to additional information received, there was no malfunction confirmed and the allegations appear to be pointed towards the fact that the enclosure was not zipped up.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Specifically checking the zipper, the ifu warn users to, "never leave the patients bedside until all access panel zippers are completely closed.Quick-release buckles be connected and closed on all four access panels before the patient is left alone." manufacturer record #(b)(4).

Event Description

Supplemental submission based on additional information received regarding patient.The exact date of event remains unknown.

• Brand Name: POSEY BED 8070
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): J.T. POSEY COMPANY; 5635 peck road; arcadia CA 91006 0020
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6019397
• MDR Text Key: 57043407
• Report Number: 2020362-2016-00034
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2016

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: Nurse
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other