MAUDE Adverse Event Report: HILL-ROM BATESVILLE PROGRESSA FRAME; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P7500A000290

Device Problems Self-Activation or Keying (1557); Unintended Movement (3026)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

Hill-rom received a report from the customer alleging the bed began to lower on its own without an operator activating the controls.A nurse unplugged the power cord while the bed was moving which stopped the movement.The bed was located at the account in an intensive care unit specializing in cerebral injury at the time of the incident.This report was filed in our complaint handling system as (b)(4).

Manufacturer Narrative

The bed was thoroughly inspected by hill-rom technicians and engineers.Potential root causes were explored during the analysis including: mechanical related fault: the cpr pin/drive assembly was assembled and performed as designed.No interference with the cpr pedal and covering shroud was found.Electrical shorts in the side rails: the side rails were dismantled to determine if there were any pinched or damaged cabling.All cables were intact and in good condition, ruling out damaged/pinched cables as a root cause.All the side rail buttons functioned as designed and did not stick causing a self-run behavior.Fluid ingress: no evidence of fluid ingress was found to any of the control boards.Electrical shorts in the control pendant: the pendant was inspected for signs of damage to the cord, plastic housing, and buttons, verifying that there was no visible damage.The pendant was functioning as designed.The investigation team was unable to replicate the failure and found no issues with the bed.Since there was a pendant installed on the bed during the incident, the most probable root cause is accidental pressing of the pendant controls due to a misplaced pendant (such as between the mattress and frame).If the bed is unplugged while articulating, the articulation stops and will not continue unless the button on the pendant is released and then depressed again.This design fits the narrative from the complaint that the bed stopped moving once the bed was unplugged.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the customer alleging the bed began to lower on its own without an operator activating the controls.A nurse unplugged the power cord while the bed was moving which stopped the movement.The bed was located at the account in an intensive care unit specializing in cerebral injury at the time of the incident.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: PROGRESSA FRAME
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 7764305
• MDR Text Key: 116733868
• Report Number: 1824206-2018-00300
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P7500A000290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2015
• 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