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

Model Number P1840DCA000001

Device Problem Activation Problem (4042)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the cpr valve needed to be replaced.Per the hillrom service manual the totalcare bed system requires an effective maintenance program.We recommend that you perform a semi-annual preventative maintenance.Test the cpr release for correct operation and reset of the head cylinder.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the cpr valve to resolve the reported event.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the bed 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: TOTALCARE BARIATRIC CAPITAL
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: estephania cardenas ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17749988
• MDR Text Key: 323700884
• Report Number: 1824206-2023-01068
• Device Sequence Number: 1
• Product Code: IOQ
• UDI-Device Identifier: 00887761000865
• UDI-Public: 010088776100086511200414
• 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: 09/14/2023

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: P1840DCA000001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2020
• 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