MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD DRIVE DEVILBISS HEALTHCARE; BED, MANUAL

Model Number	15201BV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bed half rail by a provider who reported that the half rail came off the bed when caregivers were turning the patient, causing them to fall off the bed and break their collar bone, requiring hospital treatment.Drive devilbiss healthcare is currently investigating the incident, including confirming the sku of the half rail involved in the incident, since the sku originally reported is different than the half rail that was returned to drive for evaluation.In addition, since the returned rail was observed to be intact and unbroken, drive is gathering further information regarding how the half rail was attached to the bed.An update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: BED, MANUAL
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO. LTD; no.61 &96 zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 18230790
• Report Number: 2438477-2023-00143
• Device Sequence Number: 5531749
• Product Code: FNJ
• UDI-Device Identifier: 00822383143026
• UDI-Public: 00822383143026
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section F): 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 15201BV
• Device Catalogue Number: 15201BV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• 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 Sex: Male
• Date Report Sent to FDA: 11/29/2023