MAUDE Adverse Event Report: HILL-ROM MEXICO FLAT DECK 36" MRS W/ X-RAY SLV; BED, FLOTATION THERAPY, POWERED

Model Number P7924ARENT01

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 03/27/2024

Event Type  malfunction  

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.The technician replaced the power cord to resolve the reported event.Based on this information, no further action is required.

Event 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).

• Brand Name: FLAT DECK 36" MRS W/ X-RAY SLV
• Type of Device: 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: 19075456
• MDR Text Key: 339989259
• Report Number: 3006697241-2024-00028
• Device Sequence Number: 1
• Product Code: IOQ
• UDI-Device Identifier: 00887761976863
• UDI-Public: 010088776197686311210924
• 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: 04/09/2024

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: P7924ARENT01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• 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