MAUDE Adverse Event Report: HILL-ROM BATESVILLE SYNERGY AIR ELITE BLOWER; BED FLOTATION THERAPY POWERED

Model Number P6881

Device Problem Sparking (2595)

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

Event Date 02/02/2022

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the power cord had been ripped out of the blower and the blower needed to be replaced.The hillrom® synergy® air elite enables caregivers to create customized treatments for their patients.The surface provides flexibility throughout the healing period by providing the option to choose alternating pressure therapy when your patient needs it.The comfort control feature facilitates pressure redistribution to suit the individual needs of your patient and the low-air-loss capability helps keep your patient's skin cool and dry.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in april 2021.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the blower to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the power cord had damage and was sparking.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: SYNERGY AIR ELITE BLOWER
• 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: 13480718
• MDR Text Key: 285241767
• Report Number: 1824206-2022-00053
• 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
• Report Date: 02/08/2022

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: P6881
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 02/08/2022
• 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