MAUDE Adverse Event Report: INVACARE TAYLOR STREET PRONTO M41 SEMI-RECLINE SEAT WITH RED BASE 9153645842; WHEELCHAIR, POWERED

Model Number NA:M41SRR

Device Problems Break (1069); Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts were made to obtain additional information regarding how this damage occurred.Pictures were provided and confirmed the seat post was broken away from the frame at the weld.It was unclear based on the available information if the damage was the result of a malfunction, user damage, or use past its expected life.The underlying cause of this damage could not be confirmed, but from the pictures and description the malfunction appears consistent with a known issue.A design change was implemented october 31st 2012 regarding this type of failure.This device was manufactured in august of 2011 making it over 7 years old which is past the end of life of 5 years.This device was discontinued december of 2012.This device was manufactured by invacare (b)(4).However, invacare (b)(4) is no longer active therefore the mdr will be filed under invacare (b)(4).

Event Description

The provider stated that the seat post receiver was broken off the base frame.The caller was unaware of how this happened.

• Brand Name: PRONTO M41 SEMI-RECLINE SEAT WITH RED BASE 9153645842
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 8750176
• MDR Text Key: 149701893
• Report Number: 1525712-2019-00018
• Device Sequence Number: 1
• Product Code: ITI
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:M41SRR
• Device Catalogue Number: M41SRR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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