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

Model Number P3255A02

Device Problems Inflation Problem (1310); Appropriate Term/Code Not Available (3191)

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

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported the seat section is wearing down on the pro plus mattress with use on a versacare frame.During hillrom¿s inspection of the device, account confirmed that there was no injury to a patient.Inspection of the mattress by hillrom found the mattress was working properly.The foam in the mattress was noted to be worn.Based on the limited details available, the root cause of the reported event cannot be determined.Additionally, at this time functionality of the device cannot be confirmed as this investigation is still ongoing to determine specific details of the reported event.If any additional relevant details are received following the completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

The customer reported the seat section is wearing down on the pro plus mattress with use on a versacare frame.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).

Manufacturer Narrative

The customer reported the seat section is wearing down on the pro plus mattress with use on a versacare frame.During hillrom¿s inspection of the device, account confirmed that there was no injury to a patient.Inspection of the mattress by hillrom found the mattress was working properly.The foam in the mattress was noted to be worn.Based on the limited details available, the root cause of the reported event cannot be determined.Additionally, at this time functionality of the device cannot be confirmed as this investigation is still ongoing to determine specific details of the reported event.If any additional relevant details are received; however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

The customer reported the seat section is wearing down on the pro plus mattress with use on a versacare frame.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: VERSACARE MRS W/O X-RAY
• 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: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 16834782
• MDR Text Key: 314209298
• Report Number: 3006697241-2023-00037
• Device Sequence Number: 1
• Product Code: IOQ
• 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,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P3255A02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2022
• 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