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

Model Number	1222P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2022
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare was notified on an incident involving a bed rail by a provider who reported that the end user collapsed against the bed pushing the mattress to create a space between the mattress and bed rail and trapped the end user.The nurse was able to free the end user's head and confirm that the end user was still breathing.Ems arrived to transport the end user to the hospital, but the end user expired on the way to the ambulance.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.
Additional Manufacturer Narrative
(b)(6) healthcare incorrectly reported section b4 as 06/21/2024 on mdr 2438477-2024-00032.The correct date for section b4 is 06/24/2024.

• 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: 19601809
• Report Number: 2438477-2024-00032
• Device Sequence Number: 8121256
• Product Code: FNJ
• UDI-Device Identifier: 00822383543451
• UDI-Public: 00822383543451
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024
• Report Date (Section F): 06/24/2024

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: Lay User/Patient
• Device Model Number: 1222P
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/11/2024
• Event Location: Home
• Date Report to Manufacturer: 06/24/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 06/25/2024
• 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: Death
• Patient Sex: Male
• Date Report Sent to FDA: 06/24/2024