MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-02-01 for AQUATEC OCEAN VIP AND SOFT SEAT 1470713 manufactured by Aquatec Gmbh.
[134710377]
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.
Patient Sequence No: 1, Text Type: N, H10
[134710378]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007231105-2019-00001 |
| MDR Report Key | 8296433 |
| Report Source | OTHER |
| Date Received | 2019-02-01 |
| Date of Report | 2019-01-04 |
| Date of Event | 2015-09-19 |
| Date Mfgr Received | 2019-01-25 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2019-02-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | AQUATEC GMBH |
| Manufacturer Street | ALEMANNENSTRASSE 10 |
| Manufacturer City | ISNY, BADEN-WURTTEMBERG |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUATEC OCEAN VIP AND SOFT SEAT |
| Generic Name | CHAIR, ADJUSTABLE, MECHANICAL |
| Product Code | INN |
| Date Received | 2019-02-01 |
| Model Number | 1470713 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AQUATEC GMBH |
| Manufacturer Address | ALEMANNENSTRASSE 10 ISNY, BADEN-WURTTEMBERG US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-01 |