MAUDE Adverse Event Report: AQUATEC OPERATIONS GMBH AQUATEC OCEAN ERGO DUAL VIP W/COLLECTION PAN/LID/PAN SUPPORT RAIL/9153661140; ADAPTOR, HYGIENE

Model Number OCEANERGODUALVIP

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Head Injury (1879)

Event Type  Injury  

Manufacturer Narrative

The device has not been received by aquatec operations, gmbh.Should additional information become available this record will be updated.

Event Description

While taking a shower the back of the aquatec ocean ergo shower commode chair broke entirely off the frame causing the user to fall backwards onto the shower floor.The caregiver was present but not able to stop or brace the backwards fall.The user's father, a practicing infectious disease doctor, stated that he managed his son as a typical closed head injury and he is doing very well.

• Brand Name: AQUATEC OCEAN ERGO DUAL VIP W/COLLECTION PAN/LID/PAN SUPPORT RAIL/9153661140
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): AQUATEC OPERATIONS GMBH; 10 alemannenstr; isny 88316 ; GM 88316
• Manufacturer (Section G): AQUATEC OPERATIONS GMBH; 10 alemannenstr; isny 88316 ; GM 88316
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 10408361
• MDR Text Key: 202962033
• Report Number: 3007231105-2020-00001
• Device Sequence Number: 1
• Product Code: ILS
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: OCEANERGODUALVIP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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): Other
• Patient Age: 30 YR