Description of Event or Problem · 0
IT WAS REPORTED THAT, IN A HOME SETTING, A BEDSIDE SPO2 MONITOR WAS USED WITH A THIRD-PARTY PEDIATRIC SENSOR AND THE USER WAS UNABLE TO OBTAIN AN SPO2 READING, EXPERIENCED CONTINUOUS DROPOUT OR INTERMITTENT LOSS OF THE SPO2 READING AND OBSERVED A LOW SPO2 READING REPORTED AS A READING ISSUE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS BEING ASSOCIATED WITH THIS EVENT. FDA CODE: 2460. DESCRIPTION: LOW READINGS. FDA CODE: 2199. DESCRIPTION: NO CONSEQUENCES OR IMPACT TO PATIENT DESCRIPTION: INACCURATE PARAMETER VALUE. FDA CODE: 4582. DESCRIPTION: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS FDA CODE: 2199. DESCRIPTION: NO HEALTH CONSEQUENCES OR IMPACT. LOW READINGS - SPO2 AND PULSE RATE. 1. DOES THE COMPLAINT MEET THE DEFINITION OF AN INCIDENT? ANSWER: YES, PROCEED TO #2. 2. CAUSAL RELATIONSHIP BETWEEN INCIDENT AND DEVICE OR CAUSAL RELATIONSHIP REASONABLY POSSIBLE? (PRODUCT CONSIDERED CONTRIBUTORY CAUSE?) ANSWER: YES, PROCEED TO #3. 3. DIRECTLY OR INDIRECTLY LED, MIGHT HAVE LED OR MIGHT LEAD TO DEATH OF A PATIENT, USER OR OTHER PERSON; TEMPORARY OR PERMANENT SERIOUS DETERIORATION OF PATIENT'S, USER'S OR OTHER PERSON'S STATE OF HEALTH? ANSWER: YES, PROCEED TO #4. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".