MAUDE Adverse Event Report: PINGHU WEIFENG MATERIAL TECHNOLOGY TRANSFER BENCH 9153631800; ADAPTOR, HYGIENE

Model Number 98071

Device Problems Bent (1059); Out-Of-Box Failure (2311)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

The dealer states that the bracket is bent where the arm rail attaches to the device; out of box failure.

Manufacturer Narrative

(b)(4).This product was returned with the date code of (b)(4).The manufacture is (b)(4).This is not a reportable event by invacare.Invacare will notify oem by an oem notification.The device was evaluated by the returns department which found that the seat arm bent and won't align with transfer bench due to freight damage.

Event Description

The dealer states that the bracket is bent where the arm rail attaches to the device; out of box failure.

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

• Brand Name: TRANSFER BENCH 9153631800
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): PINGHU WEIFENG MATERIAL TECHNOLOGY; 1200 taylor street; pinghu OH 44036 ; CH 44036
• Manufacturer (Section G): PINGHU WEIFENG MATERIAL TECHNOLOGY; 1200 taylor street; pinghu OH 44036 ; CH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4817556
• MDR Text Key: 6010845
• Report Number: 1525712-2015-03238
• Device Sequence Number: 1
• Product Code: ILS
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 98071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other