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

Model Number P6881

Device Problem Sparking (2595)

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

Event Date 07/09/2023

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the device power cord was damaged and sparked.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 power cord needed to be replaced.Per the hillrom service manual inspect power cord for damage, twisting and replace if necessary.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed on september 2, 2022.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the power cord to resolve the reported event.Based on this information, no further action is required.

• Brand Name: BLOWER ASSEMBLY, SAE
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17372224
• MDR Text Key: 320133053
• Report Number: 1824206-2023-00782
• 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: 07/21/2023

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: P6881
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2023
• Initial Date FDA Received: 07/21/2023
• 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