MAUDE Adverse Event Report: HILL-ROM BATESVILLE PROGRESSA FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P7500A000131

Device Problem No Audible Alarm (1019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the progressa bed exit alarm did not work, and the patient fell out of the bed.The customer also stated the patient was not injured.The progressa® bed is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The progressa® bed is intended to provide a patient support to be used in health care environments.Theprogressa® bed may be used in a variety of settings including, but not limited to,acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (pacu), and sections of the emergency department (ed).The progressa® bed is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.Per the hillrom user manual, warning: the bed exit alarm system is not intended as a substitute for good nursing practices.The bed exit alarm system must be used in conjunction with a sound risk assessment and protocol.Per the hillrom user manual, if the bed exit alarm does not alarm and all three mode indicators are flashing, remove the patient and zero the bed exit system.An inspection performed by a hillrom technician noted that the bed's graphical caregiver interface screen was damaged and broken, also the sidecomm control board connection was bent and damaged.The field service technician replaced the graphical caregiver interface pod and sidecomm board to resolve the alleged issue.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.In this event, the reported fall did not result in patient injury, however, if a similar event were to recur (bed exit alarm not working), it would likely cause or contribute to a serious injury or death.Prevention of this type of events is outlined in the device ifu as noted above.The technician replaced the graphical caregiver interface pod and sidecomm board to resolve the alleged issue.Based on this information, no further action is required.

Event Description

It was reported that the progressa bed exit alarm did not work, and the patient fell out of the bed.The customer also stated the patient was not injured.This report was filed in our complaint handling system as complaint #: (b)(4).

• Brand Name: PROGRESSA FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18354772
• MDR Text Key: 331189023
• Report Number: 1824206-2023-01422
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761000100
• UDI-Public: 010088776100010011160926
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2023

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 Model Number: P7500A000131
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1