MAUDE MDR 9732060

MDR report key
9732060
Report number
9732060
Event key
0
Event type
3
Date of event
2020-01-23
Date received
2020-02-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Related Records

Manufacturer Contact

Report source
U
Manufacturer link flag
N

Devices

SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NASAL ALAR SP02 SENSOROXIMETERXHALE ASSURANCE, INC.DQA301-11214* *

Patients

SequenceReceivedTreatmentOutcome
12020-02-2001. O

Event Narratives

D

Patient 1

SKIN BREAKDOWN (BURN VS. PRESSURE-RELATED BREAKDOWN) NOTED AT PATIENT NARE WHERE PULSE OXIMETRY SENSOR DEVICE HAD BEEN IN PLACE. SIMILAR SKIN BREAKDOWN NOTED IN A SECOND PATIENT IN A DIFFERENT ICU LOCATION. BOTH PATIENTS IN CRITICAL CARE SETTINGS WITH VASOPRESSOR(S) INFUSION REQUIREMENTS. SUSPECT POSSIBLE ISSUE WITH STAFF NOT ROTATING THE PROBE SITE AS FREQUENT AS PER MANUFACTURER RECOMMENDATIONS FOR PATIENTS AT HIGH RISK OF SKIN BREAKDOWN. MORE EDUCATION IS LIKELY WARRANTED. RECOMMENDATIONS FROM MANUFACTURER HAVE BEEN (FOR HIGH RISK POPULATION) TO ROTATE SITE EVERY 4 HOURS AND ASSESS SITE AT LEAST EVERY 2 HOURS.

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