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

Model Number P3930A000026

Device Problem Component Missing (2306)

Patient Problem Laceration(s) (1946)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

The facility maintenance stated that the edge guards were missing from the frame.The account has ordered replacement edge guards and will install them upon receipt of the parts.Per the hillrom service manual: do a periodic inspection to make sure all bed functions operate correctly, especially the safety features.Safety features include, but are not limited, to these: connectors where the bed sections bolt together; tighten as necessary, siderail latching mechanisms, caster braking systems, edge guards; make sure that edge guards are not broken or loose.Only remove an edge guard that is damaged or loose.If the bed is used without the edge guards, personal injury can occur.As no serial number was provided for this bed, a search of the hillrom maintenance records for any hillrom performed preventative maintenance on this bed was unable to be completed.It is unknown if the facility performs preventative maintenance on their beds.The customer has ordered replacement edge guards and will install the edge guards upon receipt of the parts.Based on this information, no further action is required.

Event Description

Hillrom received a report from the account stating the bed had no edge guard on the frame of the bed.The patient sustained a minor laceration.The bed was located at the account.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: GPAC FRAME-ASSEMBLED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 11622960
• MDR Text Key: 245550293
• Report Number: 1824206-2021-00160
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P3930A000026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1