MAUDE Adverse Event Report: AQUATEC GMBH AQUATEC OCEAN VIP AND SOFT SEAT; CHAIR, ADJUSTABLE, MECHANICAL

Model Number 1470713

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Encephalopathy (1833); Bone Fracture(s) (1870)

Event Date 09/19/2015

Event Type  Injury  

Manufacturer Narrative

The medwatch report was submitted by an attorney who is representing a defendant named in a lawsuit.Their contact information is not available.The lawsuit alleges that a nurse used the aquatec ocean vip shower commode chair to transfer the patient to the bathroom, and she lost control of the chair, causing the chair to fall over with the patient in the chair.The patient sustained multiple fractures to his left leg and right arm, and he experienced encephalopathy/hypoxic-ischemic injury.He was hospitalized for two months, and he required surgery to correct the femur fracture.The lawsuit alleges that the nurse's negligence caused the patient's injuries.It states that the aquatec ocean vip shower commode chair was in sound mechanical and functioning condition at the time the nurse was using it to transfer the patient.It also states that the physical premises where the nurse was using the chair were safe, presented no hazards, and did not cause or contribute to the chair falling over.Invacare did not have an opportunity to inspect the subject chair, and the exact circumstances surrounding the event are unknown.However, based on the available information, a device malfunction did not occur.Rather, the most likely cause of the event is use error.The aquatec ocean vip user manual warns of the risks of the chair tipping over if the front casters are facing backward and the patient¿s weight is forward.If the chair is used properly, as instructed in the manual, then the risk of the chair tipping forward is mitigated.The subject chair was manufactured in february 2009.The front anti-tippers were made available as an after-market option in april 2013.Invacare determined that a field action in the us was not required.The addition of the anti-tippers was not a result of a product non-conformance/malfunction.The front anti-tippers are not required to maintain stability of the chair.The chair meets the necessary stability requirements without anti-tippers installed.The anti-tippers are an optional accessory that provide additional safety to prevent the chair from tipping forward in the event the product is not used properly.

Event Description

A medwatch report was located on the fda maude database alleging that a patient was being transferred in an aquatec ocean vip shower commode chair when it tipped forward and caused him injury that resulted in hospitalization.The incident allegedly occurred when the shower chair¿s casters were in the rear position and the patient's body was positioned forward.The report indicated that invacare had issued a field safety notice in a foreign market regarding the aquatec ocean vip.The field safety notice warns that the chair may tip forward under the circumstances that occurred on the date in question and that the hazard can be addressed by affixing after-market anti-tippers.The report alleges that since the field safety notice was not distributed in the us, neither the patient nor providers were aware of the tipping hazard.The report indicated that an engineer concluded that the incident would not have occurred had the anti-tippers been affixed to the chair.

Manufacturer Narrative

Invacare received copies of expert reports from the lawyer representing the patient's family.The report states that the rn caring for the patient said she rolled the chair and patient into the hallway.The chair had a custom (non-invacare) tray and contoured seat and was stationary when the rn moved to the front of the chair to talk with the patient.The rn said she believes she locked the wheels.The chair's headrest reportedly slipped downwards causing the patient to move to his right.The rn moved to the side of the chair to reposition the patient.In the process, the rn states the patient forcefully moved toward the tray and chair tipped forward onto the ground.The rn attempted to hold the patient but was unsuccessful.It was the export's conclusion/opinion that: the addition of the non-invacare tray increased the risk and was a contributing factor to the incident; had the rn placed the casters in the leading (forward) position, the incident would be less likely to occur; and had invacare anti-tippers, available at the time of the incident, been properly installed, the incident would not have occurred.The tray which the expert concluded ¿increased the risk¿ and was ¿a contributing factor¿ to the incident, was not manufactured or installed by invacare.Invacare does not conduct testing of non-invacare trays on the aquatec vip chair and does not recommend use of non-invacare trays.Invacare makes no claims of safety or effectiveness related to non-invacare trays.The expert report states if front anti-tippers were installed, ¿the incident would not have occurred.¿ the invacare manufactured anti-tippers were available at the time of the incident.Invacare is not aware of specific patient medical conditions and needs when chairs are ordered and produced.Invacare relies on dealers and clinicians to properly assess patient needs and order products which meet the specific patients¿ needs.At the time when the subject wheelchair was produced, the owner¿s manual which shipped with the aquatec vip chair warned of tipping if front casters were facing backwards with body weight forward.Invacare requires its distributors to provide literature from the factory to persons purchasing the product.This includes caregivers, patients, and clinicians.

Event Description

A medwatch report was located on the fda maude database alleging that a patient was being transferred in an aquatec ocean vip shower commode chair when it tipped forward and caused him injury that resulted in hospitalization.The incident allegedly occurred when the shower chair¿s casters were in the rear position and the patient's body was positioned forward.The report indicated that invacare had issued a field safety notice in a foreign market regarding the aquatec ocean vip.The field safety notice warns that the chair may tip forward under the circumstances that occurred on the date in question and that the hazard can be addressed by affixing after-market anti-tippers.The report alleges that since the field safety notice was not distributed in the us, neither the patient nor providers were aware of the tipping hazard.The report indicated that an engineer concluded that the incident would not have occurred had the anti-tippers been affixed to the chair.

• Brand Name: AQUATEC OCEAN VIP AND SOFT SEAT
• Type of Device: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): AQUATEC GMBH; alemannenstrasse 10; isny, baden-wurttemberg
• MDR Report Key: 8296433
• MDR Text Key: 134710377
• Report Number: 3007231105-2019-00001
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1470713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR