MAUDE Adverse Event Report: J. T. POSEY CO. POSEY BED

Model Number 8070

Device Problems Disconnection (1171); Inadequate or Insufficient Training (1643)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Type  Death  

Event Description

The customer reported that while in the posey bed the patient coded and expired.Reportedly, the hospital staff experienced difficulty unzipping the canopy and lowering the incline to a flat position.The charge nurse stated that the bed's plug was pulled out, which did not allow the bed to drop to a flat position.A posey representative spoke with the nurse manager and charge nurse who were on duty at the time of the event, who reported that there was no issue with the posey bed and that it worked as specified.The nurse stated that the hospital staff in charge of this patient's care does not often deal with the posey bed or patients coding.The issue unzipping the bed was related to the urgency of the event and the staff's unfamiliarity with the posey bed.Once the staff member was advised on how to unzip the posey bed, the zipper was able to be opened without issue.

Manufacturer Narrative

The posey bed was returned to the distributor and was evaluated by their biomedical engineers, who stated that the bed was functioning properly, the electrical system was in proper working condition, and the bed passed all testing.A review of the complaint database did not reveal any similar incidents of a delay opening the canopy and lowering the incline related to a serious injury or death.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, including lowering the bed and unzipping the panels.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 assessed 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.Another section in the user manual describes in detail the steps for adjusting the bed, and advises the user to "make sure the bed is connected to an appropriate ac outlet and inspect the cord for any visible kinks or cuts.Press each operation button before use to ensure the bed control is not damaged." the user is instructed that the "the double insulated power cord can be plugged into a 110-volt receptacle." additionally, the user is cautioned to "always position the power cord away from the working mechanisms of the bed.Always check the power cord for any visible kinks or cuts prior to connecting to an appropriate ac outlet.Always position the power cord away from walkways to avoid a tripping hazard." a check for proper bed assembly checklist advises the user that to complete the checklist, plug the bed power cord into a 110 volt receptacle.Detailed instructions for opening the quick release buckles and how to properly unzip the panels are also provided in the user manual.Guidelines for staff training are established in the user manual, and, once trained, each trainee receives a performance certificate to be kept on file at the facility.The user manual itself states that the "user's manual is intended for professionals providing care to patients in the posey bed who have successfully completed the posey bed in-service training program." prior to beginning use of the posey bed, posey performed an extensive in-service at this facility.After this in-service, the facility wrote a protocol for use of the posey bed based on the posey professional user manual.Within two days of this event, a posey representative provided additional training to this site.The evidence does not reasonably suggest that there was a malfunction of the posey bed.It appears that the momentary delay in opening the canopy and lowering the incline was related to the urgency of the event and unfamiliarity with the posey bed.Posey has provided additional training to the hospital staff and reiterated the instructions in the professional user manual.The instructions for use and staff training requirements were reviewed and deemed adequate for the successful use of the posey bed, and there is no evidence of a device malfunction.Therefore, no additional actions will be taken at this time.(b)(6).

• Brand Name: POSEY BED
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; de r.l. de c.v. ave. ferrocarril no. 16901; bodega tijuana CP 2 2664; MX CP 22664
• Manufacturer Contact: pam wampler, administrator ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3877039
• MDR Text Key: 4568813
• Report Number: 2020362-2014-00211
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/04/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INVACARE BED FRAME AND MOTOR, SN (B)(4)
• Patient Outcome(s): Death