MAUDE Adverse Event Report: HILL-ROM BATESVILLE TOTALCARE BARIATRIC RENTAL-NEW; BED, FLOTATION THERAPY, POWERED

Model Number P1840DRE0001

Device Problem Defective Alarm (1014)

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

Event Date 04/01/2022

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the bed exit was not alarming.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 hillrom technician found the bed exit was not alarming and the bed needed to be retired.Per the hillrom user manual, warning: the bed exit system is not intended as a substitute for good nursing practices.The bed exit system must be used in conjunction with a sound risk assessment and protocol.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in january 2022.It is unknown if the facility performed any other preventative maintenance on this bed.This bed was removed from service.Based on this information, no further action is required.

• Brand Name: TOTALCARE BARIATRIC RENTAL-NEW
• 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: 14253134
• MDR Text Key: 290944606
• Report Number: 1824206-2022-00230
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122473
• 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: 04/29/2022

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: P1840DRE0001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2011
• 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