FDA WARNING_LETTER - Childrens Medical Ventures - March 28, 2014

The FDA issued a Warning Letter to Children’s Medical Ventures/Philips Healthcare following an inspection from March 10-28, 2014, at their former Monroeville, PA, facility, which manufactures the SmartMonitor 2 PS device. The device was deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820) and misbranded under 21 USC 352 (t)(2) for failing to furnish required information.

Violations include: 1. **Failure to control nonconforming product (21 CFR 820.90(a)):** A wiring issue in 311 SmartMonitor 2 PS battery packs (lots (b)(4) and (b)(4)) caused device failures, constant alarms, and disrupted monitoring of infant respiration, heart rate, and oxygen saturation. No Health Hazard Evaluation or risk reduction activities were performed. As of March 13, 2014, 99 of 143 affected units distributed to the field remained uncontrolled. 2. **Inadequate complaint file maintenance (21 CFR 820.198(a)):** Twenty-seven service work orders related to Field Change Order (FCO) reference (b)(4) were not maintained as complaint files. 3.