MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-11-13 for IMRIS ORT100 OPERATING ROOM TABLE 108000-000 manufactured by Imris-deerfield Imaging, Inc..
[128399684]
The table power pack was replaced, including the o-ring seal. The table was functionally tested to verify proper operation.
Patient Sequence No: 1, Text Type: N, H10
[128399685]
The customer service engineer found a small hydraulic leak in the ort100 table power pack. There were no reports of the table malfunctioning or patient injury. The power pack leak was not originally identified as a table leak; therefore, it was not reported at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2018-00039 |
| MDR Report Key | 8067249 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-13 |
| Date of Report | 2018-11-13 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2017-12-12 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2018-11-13 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TODD SPERLING |
| Manufacturer Street | 5101 SHADY OAK ROAD |
| Manufacturer City | MINNETONKA MN 553434100 |
| Manufacturer Country | US |
| Manufacturer Postal | 553434100 |
| Manufacturer Phone | 7632036344 |
| Manufacturer G1 | DEERFIELD IMAGING, INC. |
| Manufacturer Street | 5101 SHADY OAK ROAD |
| Manufacturer City | MINNETONKA MN 553434100 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 553434100 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMRIS ORT100 OPERATING ROOM TABLE |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | KXJ |
| Date Received | 2018-11-13 |
| Model Number | ORT100 |
| Catalog Number | 108000-000 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMRIS-DEERFIELD IMAGING, INC. |
| Manufacturer Address | 5101 SHADY OAK ROAD MINNETONKA MN 553434100 US 553434100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-13 |