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

Model Number P7500A000131

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

Hill-rom technical support suggested checking the hand pendant to make sure it was not under the mattress.Per the hill-rom service manual, perform annual preventive maintenance procedures to make sure all versacare® bed components are functioning as originally designed.Make sure the brake is not set, and then plug the bed into an applicable power source.A steady alarm comes on.Set the brake.The alarm stops.Repair or replace as necessary.The account did not provide a serial number.Unable to search for the hill-rom maintenance records on this bed.It is unknown if the facility performs preventative maintenance on their beds.Three attempts have been made regarding a resolution to this complaint, with no response.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the bed self ran into the chair posiiton.The bed was located at the account.There was no patient/user injury reported.(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: 7764312
• MDR Text Key: 116734621
• Report Number: 1824206-2018-00299
• 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
• Report Date: 07/23/2018

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: P7500A000131
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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