Device product
Philips V60 Ventilators with Power Management PCBA part number 1055906
Z-1622-2020
Product summary
- Event
- Event 85113
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23581
- Official record key
device-enforcement:Z-1622-2020
Official wording
Reason: Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia
Code information: Serial Numbers: 100002908 to 100027093; 100027096 to 100085389; 100085399 to 100109746; 100109868 to 201003390; 201003392 to 201010952
Distribution pattern: U.S.: CO, PA, AZ, OH, MT, AR, FL, NC, KS, IL, CA, HI, MD, SC, WY, OR, NY, NE, OK, MN, UT, ND, LA, IN, AL, AK, WV, GA, WI, MI, VA, NJ, TX, WA, SD, KY, TN, MS, MO, DE, MA, VT, CT, IA, NV, ID, ME, NM, DC, NH, VI, RI, PR. O.U.S.: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Gibraltar, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jersey, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Malta, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam
Derived failure modes
-
Unknown
Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia