MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-03 for FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG 0682400034 manufactured by Stryker-communications.
[188573886]
It was reported that in or 2, the yoke separated from the flat panel spring arm. A stryker field service technician (sfst) was dispatched for investigation. During his inspection, the sfst found that the m3 safety segment screw and the keeper clip, which are used to secure the flat panel yoke to the spring arm, were missing. The sfst then proceeded with the repairs by reinstalling the yoke onto the spring arm, installing a new keeper clip into the safety segment area. The safety segment cuff was re-installed and was secured with a new m3 safety segment screw. A functional test was performed to ensure the yoke was properly secured to the spring arm. The yoke and the spring arm were found to be working to specification, and the equipment was placed back into service. The sfst interviewed the hospital staff to determine how the m3 safety segment screw and keeper clip became missing. The staff was unaware on how the hardware had become missing and were not aware of any hospital staff performing maintenance on the equipment. The installation qip for the surgical light system was properly installed and passed final qc inspection on 29oct2013. The service history investigation revealed seven service reports associated with or2, of which all equipment functional testing was performed and the equipment was found to be working to specification. Since 09feb2018, neither the surgical lights or the flat panel monitor equipment in this or have been serviced by stryker personnel. Although the exact root cause of this issue is unknown, potential root causes include improper service and maintenance by hospital personnel. There was no injury or adverse event reported. This failure mode will continue to be monitored through stryker communications? Ncmb meeting process.
Patient Sequence No: 1, Text Type: N, H10
[188573887]
It was reported that in or 2, the yoke separated from the flat panel spring arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002031963-2020-00001 |
| MDR Report Key | 9780018 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-03 |
| 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. KIMBERLY LYNCH |
| Manufacturer Street | 1410 LAKESIDE PARKWAY #100 |
| Manufacturer City | FLOWER MOUND TX 75028 |
| Manufacturer Country | US |
| Manufacturer Postal | 75028 |
| Manufacturer Phone | 9724107100 |
| Manufacturer G1 | STRYKER-COMMUNICATIONS |
| Manufacturer Street | 1410 LAKESIDE PARKWAY #100 |
| Manufacturer City | FLOWER MOUND TX 75028 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75028 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG |
| Generic Name | FLAT PANEL SPRING ARM |
| Product Code | FSY |
| Date Received | 2020-03-03 |
| Catalog Number | 0682400034 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER-COMMUNICATIONS |
| Manufacturer Address | 1410 LAKESIDE PARKWAY #100 FLOWER MOUND TX 75028 US 75028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |