MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-08 for HARMONY CONNECTPOINT manufactured by Steris Corporation - Montgomery.
[27911526]
At the facility's request, a steris service technician was dispatched to the user facility to inspect the harmony connectpoint. The technician inspected the unit and surgical lighting system and found the equipment was operating according to specification. There was no malfunction of the harmony connectpoint and no repairs or adjustments were required. The harmony connectpoint operator manual section 6. 1 states, "position the harmony connectpoint to minimize interference with operating room personnel during procedures. " the steris technician was informed that the doctor performing the procedure in this event was not familiar with the harmony connectpoint and was unaware that the dvi cord should not have been draped over the light arm during the procedure. Personnel from the facility informed the steris technician that it is the hospital's procedure to run all cords, including dvi cords, under the surgical table during patient procedures to avoid interrupting the sterile field. The doctor in this event has since been made aware of the importance of positioning the harmony connectpoint and connections so as to minimize interference with the operating room personnel during procedures. No further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[27911527]
The user facility reported that during a patient procedure, the dvi cord, connected to the harmony connectpoint, was draped over a surgical light arm to support it away from the sterile field. During the procedure, the light arm was repositioned and the dvi cord fell into the sterile field. There was no injury reported. A procedural delay was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2015-00097 |
| MDR Report Key | 5138640 |
| Date Received | 2015-10-08 |
| Date of Report | 2015-10-08 |
| Date of Event | 2015-09-08 |
| Date Mfgr Received | 2015-09-08 |
| Date Added to Maude | 2015-10-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HARMONY CONNECTPOINT |
| Generic Name | CONNECTPOINT |
| Product Code | LMD |
| Date Received | 2015-10-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-08 |