MAUDE Adverse Event Report: HILL-ROM MEXICO PRO+ VERSACARE MRS WITH X-RAY; BED, FLOTATION THERAPY, POWERED

Model Number	P3255A01
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the power cord needed to be replaced.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 search of the baxter maintenance records did not show baxter performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the power cord to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
It was reported that the power cord was damage with exposed copper wires.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).

• Brand Name: PRO+ VERSACARE MRS WITH X-RAY
• Common Device Name: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: daniela avila ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 19253897
• Report Number: 3006697241-2024-00035
• Device Sequence Number: 7321106
• Product Code: IOQ
• UDI-Device Identifier: 00887761977860
• UDI-Public: 010088776197786011211116
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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 Model Number: P3255A01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown