MAUDE Adverse Event Report: SHENZHEN GIFTSHINE TECHNOLOGY CO., LTD. DRIVE; PATIENT ALARM

Model Number	13606
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	02/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, drive devilbiss healthcare was notified of an incident regarding a pressure-sensitive chair and bed patient alarm, intended to alert a caregiver when a patient gets out of a chair or bed.The patient's daughter reported that her mother, a dementia patient, got out of bed twice within hours of each other and that the alarm failed to function both times, resulting in her mother falling twice.In the second fall, the patient hit her head "but she is ok," and no medical attention was sought.The reporter indicated that the device was plugged in to outlet power, concluding that it was "not a battery issue." drive devilbiss is currently investigating the incident, including attempting to retrieve the product to inspect it.

• Brand Name: DRIVE
• Common Device Name: PATIENT ALARM
• Manufacturer (Section D): SHENZHEN GIFTSHINE TECHNOLOGY CO., LTD.; 4f block c1 zone 4; xinxing industrial pk; xinhe comm. fuyong st., shenzhen 51810 3; CH 518103
• MDR Report Key: 13760280
• Report Number: 2438477-2022-00016
• Device Sequence Number: 12247948
• Product Code: KMI
• UDI-Device Identifier: 00822383116327
• UDI-Public: 822383116327
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2022
• Report Date (Section F): 03/10/2022

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: 13606
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/20/2022
• Device Age: 8 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2022
• 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: Female
• Patient Weight: 45 KG
• Date Report Sent to FDA: 03/10/2022