MAUDE Adverse Event Report: HILL-ROM SINGAPORE VEST, MODEL 105 BLE; PERCUSSOR, POWERED-ELECTRIC

Model Number	P105000BT
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The vest® airway clearance system instructions for use (ifu) documents several warnings for the users to help prevent injury and/or equipment damage.The following warnings should be obeyed: if this product has a damaged power cord or plug, is not working properly, or has been dropped or damaged, do not operate it.For examination and repair, contact hill-rom.Additionally, to help prevent injury and/or equipment damage during cleaning of the device, the following warnings should be obeyed: inspect the air pulse generator and garments before each use.In addition, after each cleaning cycle, visually inspect each component for any wear, tear, or deformity.If you have any concern about a component, do not use it, and replace that component before the next therapy session.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this device.The power cord was not returned by the customer for inspection.A replacement power cord was sent to the customer to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report from a baxter technician stating the device had power cord damage with exposed copper wires.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: VEST, MODEL 105 BLE
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• Manufacturer (Section D): HILL-ROM SINGAPORE; 1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 19497684
• Report Number: 3008145987-2024-00014
• Device Sequence Number: 12427463
• Product Code: BYI
• UDI-Device Identifier: 00887761997745
• UDI-Public: 00887761997745
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: P105000BT
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown