Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-1000 is a prescription medical device suitable for use in institutional, home and transport settings.
This recall has been terminated (originally issued November 23, 2005).
- Company
- Pulmonetic Systems, Inc.
- Recall Initiated
- November 9, 2005
- Posted
- November 23, 2005
- Terminated
- January 4, 2007
- Recall Number
- Z-0184-06
- Quantity
- 151
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm.
Distribution
Within the US to AK, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MI, MO, NE, NJ, NY, NV, OH, OK, OR, PA, SC, TX, UT, VA and WI. OUS to include: Belgium, Brazil, Canada, India, Italy, Korea and United Kingdom
Lot / Code Info
A01916, A01961, A02196, A02656, A02985, A03667, A03696, A03741, A03774, A03809, A04262, A05454, A06194, A06585-A06598, A06600-A06613, A06615, A06616, A06618-A06620, A06622-A06624, A06626-A06630, A06633, A06635-A06637, A06639-A06654, A06656-A06659, A06661-A06670, A06672-A06684, A06686-A06696, A06698-A06700, A06702-A06707, A06709, A06710, A06712-A06716, A06734, A06746-A06748, A06750, A06755-A06758, A06760-A06763, A06765-A06766, A06769, A06771, A06779-A06780, A06783-A06785 and A07226.
Root Cause
Other
Action Taken
Urgent Medical Device Recall letter dated 11/09/05 is being sent via certified mail to affected customers. The letter informs customers of the issue. A Pulmonetic Systems representative will contact the customer within 72 hours to schedule a printed circuit board replacement. Customers are advised that in the interim all ventilator-dependent patients should be constantly monitored by qualified personnel to ensure that if a malfunction occurs, alternate ventilation can be provided.