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

Model Number P137822

Device Problem No Audible Alarm (1019)

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

Event Date 12/22/2023

Event Type  malfunction  

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.

Event Description

Baxter received a report from a baxter technician stating the bed exit alarm was not working.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).

Event Description

Baxter received a report from a baxter technician stating the bed exit alarm was not working; failed to go off.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 baxter technician found the pneumatic box assembly replaced upper and lower head and upper and lower seat ario needed to be replaced.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in september 2019.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the pneumatic box assembly replaced upper and lower head and upper and lower seat vario to resolve the reported event.Based on this information, no further action is required.

• Brand Name: ENVISION MATTRESS 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: 18543034
• MDR Text Key: 333240772
• Report Number: 1824206-2024-00082
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/12/2024

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: P137822
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 03/12/2024
• 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