MAUDE Adverse Event Report: HILL-ROM BATESVILLE LATITUDE UPPER TELESCOPING ARM; LIGHT, SURGICAL, CEILING MOUNTED

Model Number P662A030046324701A

Device Problem Fire (1245)

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

Event Date 03/21/2022

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the latitude boom caught on fire.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

A hillrom technician reported a customer alleged a latitude boom caught on fire.No additional details were shared regarding the incident.There was no patient/user injury reported.Upon inspection by the customer¿s electrician, parts of sheathing were noted to be damaged with exposed wires found running through the conduit from the front outlets to the back outlets.A search of hillrom maintenance records for sn (b)(4) did not show hillrom performed any preventative maintenance on this device.It is unknown if the facility performs preventative maintenance on their device.The latitude arm system was sold to wittrock in 2016, which is no longer in business.Based on the event reported, reportable malfunction, and the serial number (b)(4) manufactured in 2008, hillrom considers this event reportable.

• Brand Name: LATITUDE UPPER TELESCOPING ARM
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14164322
• MDR Text Key: 298959123
• Report Number: 1824206-2022-00213
• Device Sequence Number: 1
• Product Code: FSY
• 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: 04/20/2022

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: P662A030046324701A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2008
• 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