Empirical Analysis of Medical Device-Related Adverse Events in Paediatric Units of Nigerian Tertiary Hospitals

Medical device-related adverse events in paediatric hospital units carry amplified harm potential due to children's physiological vulnerability and communication limitations, yet systematic empirical analysis of the incidence, nature, and contributing factors of device-related adverse events in Nigerian paediatric units is absent from the published literature. This study empirically analyses medical device-related adverse events in paediatric units across five Nigerian tertiary hospitals in Anambra, Ogun, Kano, Plateau, and Akwa Ibom states over an eighteen-month retrospective and prospective combined study period. Adverse event data were collected through retrospective review of incident reports, nursing notes, and mortality records over twelve months and prospective incident reporting over six months using a standardized device-related adverse event reporting form introduced at each facility. Events were classified by device category, event type (use error, malfunction, or maintenance-related failure), harm severity using the National Coordinating Council for Medication Error Reporting and Prevention harm category scale, and contributing factor categories using a healthcare human factors taxonomy. A total of three hundred and fourteen device-related adverse events were identified across the five facilities. Infusion pump programming errors were the most frequent event category, accounting for 31 percent of total events. Patient monitor alarm fatigue events were the second most frequent category. Harm severity analysis showed that nineteen percent of events caused temporary patient harm and three events contributed to patient death. Contributing factor analysis identified use-related errors as more frequent than malfunction-related events, with inadequate user training and poor device interface design identified as the most common root contributing factors. Keywords: medical device adverse events, paediatric units, tertiary hospitals, patient safety, contributing factors.