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

Model Number	15300BV-PKG
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Pain (1994)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4) is the initial importer of the device which is a bed.The weld broke and the frame came loose from the headboard.The bed slid into the wall causing the occupant to hit her head.The headboard then feel forward on top of her.Incident exacerbated her rheumatoid arthritis.Patient has heat applied to her back before sleep.

• Brand Name: DRIVE
• Common Device Name: BED BARIATRIC
• Manufacturer (Section D): SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO.,.; no. 259 jiugan road; sijing town; song jiang district, shanghai, china 20160 1; CH 201601
• MDR Report Key: 8588159
• Report Number: 2438477-2019-00023
• Device Sequence Number: 1638720
• Product Code: OSI
• UDI-Device Identifier: 00822383212319
• UDI-Public: 822383212319
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2019
• Report Date (Section F): 05/07/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: 15300BV-PKG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/10/2019
• Device Age: 21 MO
• Event Location: Home
• Date Report to Manufacturer: 05/07/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Weight: 176
• Date Report Sent to FDA: 05/07/2019