Device product
2000 Vascular with 30 Degree option
Z-0353-2020
Product summary
- Event
- Event 83219
- Status
- Terminated
- Classification
- Class II
- Quantity
- 167 beds (159 US, 8 OUS)
- Official record key
device-enforcement:Z-0353-2020
Official wording
Reason: Potential for bed to drop suddenly at the head while a patient is laying on it.
Code information: Serial Numbers: 2030, 1713, 1041, 1191, 1368, 1306, 2052, 1895, 1554, 1618, 1511, 1990, 1659, 2279, 1354, 1547, 1442, 2156, 1536, 1471, 1472, 1473, 1548, 1549, 1550, 1551, 1750, 1242, 1601, 2008, 1946, 1947, 1868, 1865, 1811, 1831, 1832, 2202, 1495, 2082, 2083, 1044, 1571, 1621, 2017, 2203, 2121, 2145, 2054, 1016, 1017, 2284, 1876, 2278, 1039, 1685, 1686,1043, 1307, 1357,2224, 2225, 1852, 1297, 2122, 2123, 1439, 1629, 2059, 1648, 1470, 1046, 1941, 1942, 1943, 1944, 1962, 1421, 885, 887, 1234, 1387, 1388, 1389, 1390, 1391, 1392, 1414, 1447, 1796, 1991, 1992, 1993, 1994, 1995, 1996, 1997, 2004, 1838, 1597, 1707, 1266, 1449, 1513, 1514,1515, 1516, 1661, 1998, 1380, 2094, 1221, 881, 886, 1058, 1095, 1189, 1243, 1267, 1377, 1379, 1399, 1400, 1420, 1453, 1458, 1477, 1498, 1527, 1581, 1608, 1616, 1617, 1654, 1676, 1677, 1785, 1814, 1872, 1904, 1905, 1906, 1907, 1917, 1918, 1961, 1973, 1974, 1975, 1984, 1985, 1999, 2000, 2001, 2002, 2012, 2013, 2014, 2029, 2046, 2055, 2056, 2057, 2063, 1708, 1793, 1794.
Distribution pattern: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, OH, OK, OR, PA, SC, TX, UT, VA, WI, WY, PR. International distribution to Canada, Saudi Arabia, Trinidad & Tobago.
Derived failure modes
-
Unknown
Potential for bed to drop suddenly at the head while a patient is laying on it.