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

Model Number	P105CM
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hillrom technician found the power cord needed to be replaced.Widely recognized as the gold standard in high frequency chest wall oscillation (hfcwo) therapy, the vest® airway clearance system has been prescribed by more physicians than any other hfcwo vest system.It is designed to help patients mobilize retained secretions¿helping them avoid respiratory infections, hospitalizations and reduced lung function.The vest system model 105 functions to provide airway clearance by using high frequency chest wall oscillation to compress and release the chest wall.It is designed to help patients mobilize retained secretions.Relative contraindications listed in the product user manual state: according to the american association for respiratory care (aarc) guidelines for postural drainage therapy, the decision to use the unit for airway clearance therapy requires careful consideration and assessment of the individual patient¿s case if the following conditions exist: chest wall pain.The technician replaced the power cord to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Hillrom received a report from a hillrom technician stating the device had power cord frayed damage with exposed copper wires.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: CONTROLLER, VEST 105
• 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: estephania cardenas ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17916668
• Report Number: 3008145987-2023-00016
• Device Sequence Number: 12458105
• Product Code: FYI
• UDI-Device Identifier: 00887761997745
• UDI-Public: 00887761997745
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

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: P105CM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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