MAUDE Adverse Event Report: APEX HEALTH CARE MFG., INC. HOYER STATURE; PATIENT LIFT, PRODUCT CODE: FSA

Model Number HOY-STATUREWSC

Device Problem Material Separation (1562)

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

Event Date 09/21/2017

Event Type  Injury  

Event Description

We received the medwatch form 3500a from our customer: joerns healthcare and it stated as below: it was reported to the manufacturer by the end user, per the end user, staff was lifting the patient and the leg of the lift snapped off and the patient feel to the floor.The patient was sent to the hospital and sustained a fractured right hip.It was entered into joerns system to have the lift returned to joerns for investigation.As of this writing, we have not yet obtained the update news.

• Brand Name: HOYER STATURE
• Type of Device: PATIENT LIFT, PRODUCT CODE: FSA
• Manufacturer (Section D): APEX HEALTH CARE MFG., INC.; no. 6, industrial 2nd road,; tou chiao industrial park,; min hsiung shiang, chai yi, tw ; TW
• Manufacturer (Section G): APEX HEALTH CARE MFG., INC.; no. 6, industrial 2nd road,; tou chiao industrial park,; min hsiung shiang, chai yi, tw ; TW
• Manufacturer Contact: carol liao ; no. 6, industrial 2nd road,; tou chiao industrial park,; min hsiung shiang, chai yi, tw ; TW
• MDR Report Key: 6995655
• MDR Text Key: 90835892
• Report Number: 3010605276-2017-00005
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HOY-STATUREWSC
• Device Catalogue Number: HOY-STATUREWSC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 136