NELLCOR PURITAN BENNETT
Received May 14, 1997
Report 2025525-1997-00006 · MDR key 92370
Device
Generic name
Central Monitoring System
Manufacturer
Puritan-bennett Corp.Model number
N7500Catalog number
NA
Lot number
NA
Product problems
- Low Audible Alarm
Patient
UNKNOWN
- Hypoxia
Narrative
Description of Event or Problem
USER REPORTS THAT CENTRAL MONITORING STATION'S AUDIBLE ALARM VOLUME WAS TOO LOW TO HEAR. A CAREGIVER HEARD THE BEDSIDE MONITOR ALARM AS THEY WALKED BY THE PT'S ROOM. USER REPORTS THERE WAS A DELAY IN RESPONDING TO THE PT'S ACUTE DESATURATION INTO THE 80% RANGE, AND THAT SOME VENTILATOR ADJUSTMENTS WERE MADE ALTHOUGH THE EXTENT OF CHANGES IS UNKNOWN AT THIS TIME. THE PT REPORTEDLY SUFFERED NO INJURY OR IMPAIRMENT AS A RESULT OF THE ALLEGED INCIDENT. IT IS NOT VERIFIED THAT THE ALARM VOLUME WAS TOO LOW AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY NELLCOR PURITAN BENNETT THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.
Additional Manufacturer Narrative
THE N7500 CENTRAL MONITORING STATION WAS RETURNED TO NPB FOR EVALUATION. THE ALARMS WERE FOUND TO BE OPERATING APPROPRIATELY. THE CUSTOMER'S REPORT COULD NOT BE DUPLICATED. NPB HAS INFORMED THE HOSPITAL OF CO'S FINDINGS. NPB CONSIDERS THE MATTER TO BE CLOSED.