MAUDE Adverse Event Report: COMPAGE ENTERPRISES LTD. PATTERSON MEDICAL BED AND CHAIR ALARM; ALARM MONITOR AND 20" X 30" BE

Model Number 081580711

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 04/13/2014

Event Type  Injury  

Event Description

(b)(6) called patterson medical customer service on (b)(6) 2014 to report she found her mother on the floor of her bedroom.She took her mother to the emergency room.X-rays taken showed a right hip fracture for which she subsequently had surgery.Customer stated she used the economy alarm monitor and 20" x 30" bed pad - 1 year which she had purchased on (b)(6) 2014.Customer stated, "the pad seems to be the issue where it is not reacting to when pressure released (i.E.The person laying on the pad gets up).As of (b)(6) 2014, her mother is in a nursing/home rehab facility since having her surgery on (b)(6) 2014.

• Brand Name: PATTERSON MEDICAL BED AND CHAIR ALARM
• Type of Device: ALARM MONITOR AND 20" X 30" BE
• Manufacturer (Section D): COMPAGE ENTERPRISES LTD.; unit 1, 16f aitken vanson; 61 hoi yuen, rd.; kwun tong ; HK
• Manufacturer Contact: frank tiemann ; unit 1, 16f aitken vanson; 61 hoi yuen rd.; kwun tong 852 ; HK 852 ; 5713923098
• MDR Report Key: 3849608
• MDR Text Key: 4657238
• Report Number: 2128677-2014-00001
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/09/2014

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
• Device Operator: Lay User/Patient
• Device Model Number: 081580711
• Device Catalogue Number: 080562537/081580711
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/14/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2014
• Distributor Facility Aware Date: 04/15/2014
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 05/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 59