Recall Z-0872-2009 ยท CBK Ventilator, Continuous, Facility Use
MAQUET Inc.
SERVO Ventilator 300A (SV300A); Maquet Critical Care Ab, Solna, Sweden. The device is intended for general and critical ventilatory care of adult, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside and for intra-hospital transport. It is not intended for transport use in ambulances or in helicopters in the US market.
| Date | Feb 3, 2009 (initiated Dec 19, 2008) |
| Status | Terminated |
| Reason | SERVO Ventilator 300A could cause hypoventilation if the use of the PC or PRVC mode with the Automode function set to "On" in Neonatal and Pediatric patient ranges with small tidal volumes and short set inspiratory rise time. |
| Root cause | Device Design |
| Action | URGENT: Device Correction letters were sent out on December 22, 2008. Letters alert users to the potential problem and the situation in which it may occur. Letter indicate the set inspiratory rise time should be set in the range of 7-10% and that the humidifier chamber water level be maintained according to manufacturers instructions. The letter is enclosed as a supplement to the SV300A Operating Manual. Consignees were directed to complete a "Device Correction-Customer Fax Response" to indicate number of units of the affected product and that they followed the instructions for including th |
| Quantity | 3,688 units in US |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970839 | SERVO VENTILATOR 300A Siemens Elema AB, Oct 14, 1997 |