MAUDE Adverse Event Report: APEX HEALTH CARE MFG. INC. HOYER PATIENT LIFT; ELECTRIC PATIENT LIFT

Device Problems Detachment of Device or Device Component (2907); Misassembly by Users (3133)

Patient Problems Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946)

Event Date 11/28/2014

Event Type  Injury  

Event Description

(b)(4).

• Brand Name: HOYER PATIENT LIFT
• Type of Device: ELECTRIC PATIENT LIFT
• 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: 4592072
• MDR Text Key: 5470907
• Report Number: 3010605276-2015-00001
• 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: 03/04/2015

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: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: No
• 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