SUPPORT ARM 178
Received Mar 8, 2019 · Event occurred Feb 28, 2019
Report 8010042-2019-00147 · MDR key 8404259
Device
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
IT WAS NOTED THAT THE RAIL CLAMPS DOUBLE PUSH BUTTON DESIGN WITH THE 2 BALL BEARINGS TENDS TO GET STUCK IN THE ADJUSTMENT POSITION AND DON¿T ALWAYS RELEASE. THIS HAS MOST LIKELY CONTRIBUTED TO THE DISENGAGING OF THE SUPPORT ARM FROM THE VENTILATOR CARRIER. THE ROOT CAUSE WHY THE REPORTED SUPPORT ARMS LEVER ACTUATOR GOT STUCK HAS NOT BEEN ESTABLISHED DUE TO THE LACK OF RETURNED PART. WORK ON AN IMPROVED RAIL CLAMP IS CURRENTLY UNDERWAY BY BY OUR RESEARCH AND DEVELOPMENT DEPARTMENT.
Description of Event or Problem
IMPORTER REF. #:(B)(4). MANUFACTURER REF. #: 1909MCC0859.
Additional Manufacturer Narrative
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERON: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM FOR PATIENT TUBES FELL OF THE SIDE RAIL OF THE VENTILATOR. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).