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

Model Number 15201BV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 329278295
• Report Number: 2438477-2023-00143
• Device Sequence Number: 1
• Product Code: FNJ
• UDI-Device Identifier: 00822383143026
• UDI-Public: 00822383143026
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Report Sent to FDA: 11/29/2023
• Distributor Facility Aware Date: 11/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male