MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-02-13 for OCEAN VIP W/TOILET PAN HOLDER AND PAN SOFT SEAT 9153650627 NA:1470793KIT manufactured by Aquatec Operations Gmbh.
[136036110]
It was reported to invacare that a resident of a nursing facility was taken into the washroom by her daughter in a wheelchair. Staff transferred the patient into the shower commode in the washroom. After toileting, the daughter was wheeling the mother in the shower commode. As the shower chair crossed over the threshold, the wheel of the shower commode caught on the threshold. The mother pitched forward and fell out the chair face forward, hitting the floor. She was taken to the hospital. The resident sustained an inter-cranial hemorrhage (not major) and was monitored at the hospital for 24 hours, then released without admission with no further concern. The invacare territory business manager visited the facility where it was confirmed that there was no malfunction with the shower commode chair. The resident was wheeled out of the washroom in the shower commode chair, not her wheelchair. The user manual states that this product is to be used only on flat smooth surfaces. The resident's daughter confirmed that her mother was not positioned properly. The mother is a large heavy woman and was not sitting all the way back in the chair, thus the center of gravity was out of balance.
Patient Sequence No: 1, Text Type: N, H10
[136036111]
An invacare territory business manager (tbm) reported that a resident was being wheeled out of a washroom at a facility by a family member in an ocean vip w/toilet pan holder and pan soft seat (tilt-in-space shower commode chair) when the caster wheel hit the threshold causing the resident to fall from the chair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007231105-2019-00002 |
| MDR Report Key | 8335280 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-02-13 |
| Date of Report | 2019-01-22 |
| Date of Event | 2019-01-19 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2018-10-01 |
| Date Added to Maude | 2019-02-13 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 OPERATIONS GMBH |
| Manufacturer Street | ALEMANNENSTRASSE 10 |
| Manufacturer City | ISNY 88316 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 88316 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OCEAN VIP W/TOILET PAN HOLDER AND PAN SOFT SEAT 9153650627 |
| Generic Name | DAILY ACTIVITY DEVICE |
| Product Code | ILS |
| Date Received | 2019-02-13 |
| Model Number | NA:1470793KIT |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AQUATEC OPERATIONS GMBH |
| Manufacturer Address | ALEMANNENSTRASSE 10 ISNY 88316 GM 88316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-13 |