MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT (SUZHOU) CO.,LTD HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679; 9805P

Model Number NA:9805P

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The 9884p painted adjustable base only for the 9805p lift was returned for evaluation, and subsequent testing verified the complaint.Per the evaluation, front end of left leg bent upward.The underlying cause could not be determined.If more information is received a supplemental report will be filed.

Event Description

Dealer states the left leg is bent and raised off of the floor.

• Brand Name: HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679
• Type of Device: 9805P
• Manufacturer (Section D): INVACARE REHABILITATION EQUIPMENT (SUZHOU) CO.,LTD; no.5 weixi road, sip; suzhou, jiangsu 21512 1; CH 215121
• Manufacturer (Section G): INVACARE REHABILITATION EQUIPMENT (SUZHOU) CO.,LTD; suzhou, jiangsu 21512 1; CH 215121
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6592244
• MDR Text Key: 76024462
• Report Number: 3008262382-2017-00010
• 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: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NA:9805P
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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 Weight: 110