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

Model Number P3930

Device Problem Insufficient Information (3190)

Patient Problem Physical Entrapment (2327)

Event Date 05/05/2023

Event Type  malfunction  

Event Description

It was reported that a patient¿s head became positioned between the mattress and siderail on the hillrom 100 low bed.The reporter inquired about bed and mattress dimensions and stated there was no patient injury associated with this event.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

It was reported that a patient¿s head became positioned between the mattress and siderail on the hillrom 100 low bed.The reporter inquired about bed and mattress dimensions and stated there was no patient injury associated with this event.Multiple attempts to obtain additional information from the customer were unsuccessful.The hill-rom® 100 low bed is a general-purpose bed for use with low to medium acuity patients in long-term care and home care environments.The device instructions for use (ifu) provides the following warning: if you purchase a replacement mattress from hill-rom or another manufacturer, make sure that the safety features of the bed have been tested and verified to operate correctly with the replacement mattress.Evaluate patients for entrapment risk, and watch patients as necessary.Make sure all siderails are fully latched when in the raised position.Failure to do so could cause serious injury or death.The device ifu provides the following information regarding mattresses: hill-rom recommends the use of hill-rom® mattresses that have been designed and tested specifically for the bed.The replacement mattress should meet the applicable regulations and technical standards to minimize the risk of injury to patients and caregivers.Mattresses should: minimize the gaps where entrapment could occur; allow enough siderail height from the top of the mattress to the top of the siderail to prevent accidental roll-overs; have appropriate firmness to assist with safe patient transfers; not interfere with siderail operation.There was no patient injury associated with the reported event.At this time, an inspection of the device has not been completed.If the reported event were to recur, it would be likely to cause or contribute to a death or serious injury.If any additional relevant information is received, the complaint will be reassessed, and the additional relevant information will be submitted in a supplemental report.Based on this information, no further action is required.

• Brand Name: GPAC
• 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: 17039319
• MDR Text Key: 317484867
• Report Number: 1824206-2023-00503
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P3930
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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