MAUDE Adverse Event Report: SHANGHAI SHUNLONG PHYSICAL THERAPY DRIVE; BED POWERED

Model Number 15300VB-PKG

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 07/17/2021

Event Type  Injury  

Event Description

On december 27, 2021, (b)(6) healthcare was notified that a fire occurred on (b)(6) 2021 in a patient's home, resulting in her death.The patient's insurer reported that "a preliminary investigation determined that the fire originated in the area of [the] hospital bed." the police report regarding the fire stated that an eyewitness to the fire "could not determine exactly what was on fire," but that there were "many electronics" "positioned next to her bed," including a wand-style liquid warmer, microwave, toaster oven and hot plate.The police report also stated that the investigating fire marshals found "several wires and cords next to" the bed, "which were associated with several different appliances.Some cords appeared stretched and some were wrapped around the rail of the bed." the police report stated that the fire marshal "could not point to a specific source" of the fire, "but suggested the fire was likely caused by one of the electrical appliances." drive is currently participating in the investigation of the fire coordinated by the attorney for the patient's insurer, including an inspection of the fire scene and all of the appliances present at the scene in the area of the fire.Drive will file an updated report once further information is available.

• Brand Name: DRIVE
• Type of Device: BED POWERED
• Manufacturer (Section D): SHANGHAI SHUNLONG PHYSICAL THERAPY; no 259 jiugan road; sijung town song; jiang district, sanghai 20160 1; CH 201601
• MDR Report Key: 13505702
• MDR Text Key: 289893597
• Report Number: 2438477-2022-00004
• Device Sequence Number: 1
• Product Code: FNL
• 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
• Report Date: 02/10/2022,01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 15300VB-PKG
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2022
• Distributor Facility Aware Date: 12/27/2021
• Device Age: 5 YR
• Event Location: Home
• Date Report to Manufacturer: 02/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female