MAUDE Adverse Event Report: HILL-ROM BATESVILLE ENVISION BLOWER KIT; BED, FLOTATION THERAPY, POWERED

Model Number P136026

Device Problems Appropriate Term/Code Not Available (3191); Activation Problem (4042)

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

Event Date 05/26/2023

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the cpr was inoperative.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

No further information is available on the repair of the bed at this time.The investigation is ongoing, 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

It was reported the cpr was inoperative for this surface.The hillrom technician inspected the device and was unable to duplicate the issue.The hill-rom® envision® surface is the peace of mind solution for managing pressure, moisture, friction and shear in patients at high risk of skin breakdown.Designed to address all four key factors affecting pressure ulcer healing, it is the surface of choice for caregivers wanting to provide an ideal safe skin environment for their compromised patients.Reports of mattress not max inflating or going flat when cpr is activated would be unlikely to cause or contribute to a death or serious injury if it were to recur.The end user has the option to use the removable headboard under the patient to provide a hard surface.A caregiver can quickly remove or attach the headboard in a single step without the use of tools.After consideration for potential harms and worst-case scenarios, no adverse health consequence is reasonably expected to result from this issue.

Event Description

Hillrom received a report from a hillrom technician stating the cpr was inoperative.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: ENVISION BLOWER KIT
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 17182898
• MDR Text Key: 317690482
• Report Number: 1824206-2023-00634
• 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: 11/15/2023

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: P136026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 11/15/2023
• 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