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

Model Number P3200K000769

Device Problem Material Frayed (1262)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Upon inspection, the hrc technician found the auxiliary power cord was frayed and bare copper wires were exposed due to abuse.Per the hillrom service manual, perform annual preventive maintenance procedures to make sure all versacare® bed components are functioning as originally designed.Examine the plug for damage.Make sure the plug is a one-piece molded plug assembly.If it is not, replace the plug cord assembly.Replace any plug cord assembly that shows any of these: discoloration of the plug molding, around the plug blades, any signs of cracking., loose fit of the plug blade (the plug blade moves in the molding), verify that the strain relief p-clip is present.Replace the power cord, if damaged.A product maintenance search was performed on this serial number resulting in no pm records found for this serial number.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the aux cord to resolve the reported event.Based on this information, no further action is required.

Event Description

The customer alleged the auxiliary power cord was damaged.There was no allegation of patient or caregiver injury or death reported from this alleged incident.This incident was captured under hillrom complaint ref # (b)(4).

• Brand Name: VERSACARE 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: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18408643
• MDR Text Key: 331525339
• Report Number: 1824206-2023-01466
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P3200K000769
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2023
• 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