MAUDE Adverse Event Report: APEX HEALTH CARE MFG. INC. HOYER PRESENCE WITH CRADLE AND SCALE; PATIENT LIFTER WITH CRADLE AND SCALE

Model Number HOY-PRESENCE4PTWSC

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Contusion (1787); Fall (1848)

Event Date 05/05/2013

Event Type  malfunction  

Event Description

Please reference importer report number (b)(4).

• Brand Name: HOYER PRESENCE WITH CRADLE AND SCALE
• Type of Device: PATIENT LIFTER WITH CRADLE AND SCALE
• Manufacturer (Section D): APEX HEALTH CARE MFG. INC.; no. 6 industrial 2nd road; tou chiao industrial park; min hsiung shiang chiayi district ; TW
• Manufacturer (Section G): APEX HEALTH CARE MFG. INC.; no. 6 industrial 2nd road; tou chiao industrial park; min hsiung shiang chiayi district ; TW
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127
• MDR Report Key: 4609745
• MDR Text Key: 5631153
• Report Number: 3010605276-2015-00002
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HOY-PRESENCE4PTWSC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2013
• Initial Date FDA Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 76