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

Model Number P7500A000295

Device Problem Defective Alarm (1014)

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

Event Date 11/18/2022

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the bed had no audible brake not set alarm.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

The hillrom technician found the external alarm needed to be replaced.Per the progressa user manual: the brake not set is an audible and visual alarm.The alarm will sound, and a message will show on the gci, when the bed is connected to an ac power source and the brake is not set.When the bed is connected to ac power and the brakes are not set, an alarm sounds and a message shows on the gci.When ac power is removed, the alarm will stop and the gci will turn off.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the external alarm to resolve the reported event.Based on this information, no further action is required.

• 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: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15857232
• MDR Text Key: 305629305
• Report Number: 1824206-2022-00510
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761000100
• UDI-Public: 010088776100010011170605
• 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: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P7500A000295
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2017
• 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