MAUDE Adverse Event Report: INVACARE GERMANY, AQUATEC BATH-BOARD MARINA H112 FACELIFT; ADAPTOR, HYGIENE

Model Number EU:1541330

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

This device was sold in the (b)(6), and this event occurred in the (b)(6).Invacare is filing this report because this device is also marketed and sold in the u.S.Invacare europe has requested the affected product for investigation at the manufacturer's site.When the investigation has been concluded a final report will be provided.

Event Description

The attendant had the patient on the mariner bath board, when two screws broke off the legs, and end user fell, breaking 2 of her ribs.

• Brand Name: BATH-BOARD MARINA H112 FACELIFT
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): INVACARE GERMANY, AQUATEC; alemannenstrasse 10; isny 88316 ; GM 88316
• Manufacturer (Section G): INVACARE GERMANY, AQUATEC; alemannenstrasse 10; isny 88316 ; GM 88316
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 8859712
• MDR Text Key: 153234343
• Report Number: 3007231105-2019-00003
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: EU:1541330
• Device Catalogue Number: 1541330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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): Required Intervention
• Patient Age: 95 YR
• Patient Weight: 60