Philips 483 Details MDR Failures

Philips Medical Systems has received a Form 483 with several observations related to medical device reporting (MDR) violations. For example, the San Jose, Calif., facility did not submit an MDR within 30 days after learning a patient ripped off a fingernail and broke a finger while pulling it out from between the table and table cover of a CardioMD table, the form says. A June 1 to 14 inspection also found Philips failed to submit MDRs for complaints describing malfunctions similar to ones already submitted as MDRs. Philips has responded to the observations and has not heard anything further from the FDA, company spokesman Ian Race said.
The GMP Letter