MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-14 for 3085 SP SURGICAL TABLE manufactured by Steris Corporation - Montgomery.
[183142421]
A steris service technician arrived onsite to inspect the table following the reported power loss. The technician was informed by the user facility's biomed department who maintain the table that prior to the reported event several of the table's fuses requirement replacement which may have resulted in the reported power loss. The 3085 sp surgical table was installed in 2002 making it approximately 18 years old and is not under steris service agreement. The user facility's biomed department is responsible for all maintenance activities. The technician was unable to perform an inspection as the table was already disassembled pending repairs by the user facility. The reported event occurred in (b)(6) 2019; however, steris was not notified of the event until receipt of this medwatch on january 15, 2020. Contrary to the user facility medwatch report, the 3085 sp surgical table is equipped with a floor lock override switch to manually unlock the table. The 3085 sp surgical table operator manual (5-3), "5. 3 floor lock override systems, a floor lock override switch is located inside the manual pump pedal recess (see figure 5-3). Flip the pedal down to access the switch (see figure 5-2). Operate the override system as follows: if no electric pump power is available: move and hold the rocker switch down to activate the unlock function and operate the foot pump (or have an assistant operate it) until the floor locks are retracted and the table is resting on its casters. To activate the lock function, move and hold the rocker switch up (or have an assistant operate it) until the table is resting on its floor locks (the casters swing freely). " the technician counseled user facility personnel on the proper use and operation of the 3085 sp surgical table, specifically how to utilize the floor lock override switch to manually unlock the table as stated in the operator manual in the event of a power loss. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[183142422]
The user facility reported via user facility medwatch report # (b)(4) that at the beginning of a patient procedure their 3085 sp surgical table "stopped working. " a procedure delay was reported as the user facility's biomed department removed the table from the operating room. The report stated that "there was no manual unlock mechanism for the bed to get it out of the room. Biomed was slowly able to unscrew the bolt that locks the bed and the bed had to be dragged out. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2020-00011 |
| MDR Report Key | 9712679 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR, OH |
| Manufacturer Country | US |
| Manufacturer Phone | 3927453 |
| Manufacturer G1 | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY, AL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3085 SP SURGICAL TABLE |
| Generic Name | SURGICAL TABLE |
| Product Code | FQO |
| Date Received | 2020-02-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY, AL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-14 |