MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-08-23 for DAILY ACTIVITY ASSIST DEVICES OCEAN XL manufactured by Invacare Canada Kirkland.
[2930133]
The dealer called stating that the right front wheel on the ocean xl aquatech shower commode chair allegedly broke during use. The consumer was provided a replacement device. No injury alleged.
Patient Sequence No: 1, Text Type: D, B5
[10034767]
(b)(4) - rma has been initiated for this issue. Model ocean xl, serial number/date code (b)(4). The consumer is a (b)(6) male whose age and height are unknown. The consumer's medical condition, stability and medication regimen are unknown. The consumer's technique while using the device is unknown. The maintenance history of the device is unknown. The dealer called stating that the right front wheel on the invacare (b)(4) ocean xl aquatec shower commode chair allegedly broke during use. The consumer's weight is reported as (b)(6). The product form #08-648c, rev 09/10 lists the weight capacity for this product at 330 lbs. The consumer exceeds the weight limitation by (b)(6) lbs. The dealer has provided the consumer with a replacement. No injury alleged. The malfunction has not been confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002416487-2012-00001 |
| MDR Report Key | 2711966 |
| Report Source | 08 |
| Date Received | 2012-08-23 |
| Date of Report | 2012-08-21 |
| Date of Event | 2012-04-05 |
| Date Mfgr Received | 2012-07-24 |
| Date Added to Maude | 2012-12-10 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN LOUGHREN |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE CANADA KIRKLAND |
| Manufacturer Street | 16769 HYMUS BLVD. |
| Manufacturer City | KIRKLAND, QUEBEC |
| Manufacturer Country | CA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAILY ACTIVITY ASSIST DEVICES |
| Generic Name | 890.5050 |
| Product Code | INB |
| Date Received | 2012-08-23 |
| Model Number | OCEAN XL |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE CANADA KIRKLAND |
| Manufacturer Address | 16769 HYMUS BLVD. KIRKLAND, QUEBEC CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-23 |