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

Model Number 8070

Device Problems Physical Property Issue (3008); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Cardiac Arrest (1762)

Event Type  Injury  

Manufacturer Narrative

Based on the information available there is no allegation of a malfunction or deficiency of the device.The posey bed professional user manual advises that ¿you must always be able to access the patient quickly in an emergency.¿ a section is devoted in the user manual to ¿emergency patient access and exit¿, which describes the steps in detail for accessing a patient in an emergency and advises users to remove the patient from the bed as necessary.A ¿guidelines for proper bed location¿ checklist is provided for use in assessing the location of the bed prior to leaving the patient¿s side.This checklist asks ¿can a patient be easily accessed and can the bed be moved to the center of the room to allow access from all four (4) sides in an emergency situation?¿ each no must be corrected before allowing a patient to occupy the bed.The posey bed canopy is used with a standard hospital mattress.There is no headboard as the canopy is designed as an enclosed compartment to help reduce the risk of patient entrapment and to provide a safe, controlled environment for patients at extreme risk of injury from a fall.In this case, it was reported that the caregivers were able to access the patient as needed and the patient was removed from the posey bed per the user manual.There is no evidence or allegation that the posey bed contributed to the patient developing cardiac arrest.This submission is based solely on the user facility's reported issue.

Event Description

The customer reported that a patient went into cardiac arrest while inside the posey bed.The caregiver brought in a backboard to lie underneath the patient and began to resuscitate.The customer reported that there was an issue with the effectiveness of the backboard due to the softness of the mattress and the fact that there was no headboard to brace the backboard against.The patient was unable to be resuscitated and was removed from the posey bed.The status of the patient is unknown at this time.The exact date of event is 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 (Section G): J.T. POSEY COMPANY; 5635 peck road; arcadia CA 91006 0020
• Manufacturer Contact: william hincy ; j.t. posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 5651177
• MDR Text Key: 45066545
• Report Number: 2020362-2016-00016
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/15/2016

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: Health Professional
• Device Model Number: 8070
• Device Catalogue Number: 8070
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening