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 |