MAUDE Adverse Event Report: INVAMEX 3 POSITION RECLINER DELUXE-X WIDE ROSEWOOD 9153641330; CHAIR AND TABLE, MEDICAL

Model Number 9RC

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.Recline slipping.

Event Description

Recliner back assembly is slipping out of place.

• Brand Name: 3 POSITION RECLINER DELUXE-X WIDE ROSEWOOD 9153641330
• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5755388
• MDR Text Key: 48344672
• Report Number: 9616091-2016-01040
• Device Sequence Number: 1
• Product Code: KMN
• 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
• Report Date: 03/09/2012

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2012
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2012
• Initial Date FDA Received: 06/28/2016
• 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