MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-11-01 for CONNECTPOINT manufactured by Steris Corporation - Montgomery.
[17156183]
The user facility reported that an anesthesiologist bent down to the floor and in the process of standing up hit his head on the harmony connectpoint. The anesthesiologist was sent to the er. The user facility declined to provide additional event information. No procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[17366976]
A steris service technician arrived onsite and inspected the connectpoint. The technician adjusted the connectpoint to several heights in a 45 degree range; the connectpoint stayed in each position. The technician tightened the brakes on the system and found that more pressure was needed to adjust arm up and down. When properly adjusted, the arm did not move down. The system was turned back to service and no further issues have been reported. Steris is filing this report due to the absence of information regarding the reported injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2013-00110 |
| MDR Report Key | 3442959 |
| Report Source | 06 |
| Date Received | 2013-11-01 |
| Date of Report | 2013-11-01 |
| Date of Event | 2013-10-02 |
| Date Mfgr Received | 2013-10-02 |
| Date Added to Maude | 2013-11-01 |
| 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 | 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 | 3 |
| Brand Name | CONNECTPOINT |
| Generic Name | INTEGRATION PACKAGE CUSTOM |
| Product Code | LMD |
| Date Received | 2013-11-01 |
| 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 | 1. Other | 2013-11-01 |