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

Model Number P136026

Device Problem Activation Problem (4042)

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

Event Date 06/07/2023

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the cpr switch needed to be replaced.Per the hillrom service manual make sure cpr for proper operation.Repair, replace, or apply touch-up paint as necessary a search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed on march 2022.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the cpr switch 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 cpr 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).

• 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: 17260265
• MDR Text Key: 318405502
• Report Number: 1824206-2023-00693
• 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
• Report Date: 07/05/2023

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?: No
• Device Model Number: P136026
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/05/2023
• 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