MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2010-12-23 for OLYMPUS CHAIR COUCH OLYMPUS OCC 7216262 manufactured by Keymed Ltd..
[1681585]
Olympus was informed of a report from a user facility in (b)(6) involving an olympus chair couch (occ) in which the metal frame supporting the back rest had reportedly sheared off. There was no apparent patient injury reported; however, if the reported phenomenon was to recur, it is conceivable that a patient injury may result.
Patient Sequence No: 1, Text Type: D, B5
[8874834]
The user facility reportedly removed the device in service along with three other identical (non-faulty) devices. The failed device has been returned to the original equipment manufacturer (oem) for further investigation. The failed device has been sent by the oem to an external specialist test house for metallurgical investigation. The exact cause of the user's experience cannot be conclusively determined at this time. If additional significant information becomes available later, this report will be updated. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611174-2010-00004 |
| MDR Report Key | 1942886 |
| Report Source | 01,06 |
| Date Received | 2010-12-23 |
| Date of Report | 2010-12-06 |
| Date of Event | 2010-12-01 |
| Date Mfgr Received | 2010-12-06 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2011-02-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | KEYMED LTD. |
| Manufacturer Street | KEYMED HOUSE, STOCK RD |
| Manufacturer City | SOUTHEND-ON-SEA, ESSEX SS25QH |
| Manufacturer Country | UK |
| Manufacturer Postal Code | SS2 5QH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS CHAIR COUCH |
| Generic Name | TREATMENT COUCH |
| Product Code | FZK |
| Date Received | 2010-12-23 |
| Returned To Mfg | 2010-12-15 |
| Model Number | OLYMPUS OCC |
| Catalog Number | 7216262 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYMED LTD. |
| Manufacturer Address | KEYMED HOUSE, STOCK RD SOUTHEND-ON-SEA, ESSEX SS25QH UK SS2 5QH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-23 |