MAUDE Adverse Event Report: SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., DRIVE; BED

Model Number 15033BV-PKG-T

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 01/26/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving an electric bed by an end user, who stated that "they were laying with the remote under her right hip and the remote control got hot and burned her." the end user went to a telehealth appointment where she reportedly told that she was "on the verge of a 1st degree burn" and prescribed ointment for treatment.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

Event Description

Drive devilbiss healthcare was notified of an incident involving an electric bed by an end user, who stated that "they were laying with the remote under her right hip and the remote control got hot and burned her." the end user went to a telehealth appointment where she reportedly told that she was "on the verge of a 1st degree burn" and prescribed ointment for treatment.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: BED
• Manufacturer (Section D): SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO.,; #259 jiugan road; sijing town; song jiang district, shanghai 20161 ; CH 20161
• MDR Report Key: 16442735
• MDR Text Key: 310233604
• Report Number: 2438477-2023-00012
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00822383211848
• UDI-Public: 00822383211848
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2023,04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 15033BV-PKG-T
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2023
• Distributor Facility Aware Date: 01/30/2023
• Device Age: 6 YR
• Date Report to Manufacturer: 03/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 109 KG