MAUDE Adverse Event Report: INVACARE CORPORATION (TW) INVACARE I-CLASS HEAVY DUTY TRANSFER BENCH; AID, TRANSFER

Catalog Number 9670U

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Blood Loss (2597)

Event Date 04/01/2019

Event Type  malfunction  

Event Description

Assisting patient with bathing and patient back against back rest.It detached and patient fell backwards, hitting head.Ct needed.Bled from prior incision.

• Brand Name: INVACARE I-CLASS HEAVY DUTY TRANSFER BENCH
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): INVACARE CORPORATION (TW); 39400 taylor pkwy; north ridgeville OH 44035
• MDR Report Key: 9181055
• MDR Text Key: 163974441
• Report Number: 9181055
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 9670U
• Device Lot Number: M 21109
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2019
• Date Report to Manufacturer: 10/09/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30660 DA