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

Model Number	P3255A02
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report from a baxter technician stating the power cord had 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).
Additional Manufacturer Narrative
The baxter technician found the power cord needed to be replaced.The hillrom pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.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.Baxter technical support provided the account the part number of the power cord that needs to be replaced to resolve the issue.The account will repair the bed themselves.Based on this information, no further action is required.

• Brand Name: PRO+ VERSACARE MRS W/O 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: estephania cardenas ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 19833664
• Report Number: 3006697241-2024-00070
• Device Sequence Number: 7513765
• Product Code: IOQ
• UDI-Device Identifier: 00887761977853
• UDI-Public: (01)00887761977853(11)240131
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/25/2024

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: P3255A02
• 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: 07/16/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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