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); Naturally Worn (2988)

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

Event Date 03/31/2023

Event Type  malfunction  

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.

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.The hillrom pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.The instructions for use (ifu) states the therapy surface is not a substitute for good nursing practice.The mattress should be used in conjunction with good assessment and protocol.Additionally, the instructions for use (ifu) states if the mattress core assembly has not exceeded its life expectancy, examine the assembly for fluid ingress and foam delamination.B) if foam delamination is present, replace the component.Determine if the deformation is excessive per facility standards.Replace or repair as necessary.The event did not result in patient injury or medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes a serious injury did not occur.If the reported problem were to recur, it would be unlikely to cause or contribute to a death or serious injury.Prevention of this type of events is outlined in the device's ifu as noted above.

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: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16833528
• MDR Text Key: 314280000
• Report Number: 3006697241-2023-00036
• Device Sequence Number: 1
• Product Code: IOQ
• UDI-Device Identifier: 00887761977853
• UDI-Public: 010088776197785311220420
• 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: 10/23/2023

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
• 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