FDA Adverse Event Injury Summary report: N

HANKISON

MDR report key: 83217 · Received February 12, 1997

Report

Report Number
83217
Event Type
Injury
Date Received
February 12, 1997
Date of Event
July 15, 1996
Report Date
July 25, 1996
Manufacturer
HANKINSON
Product Code
BTI
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
TX, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

WATER DISCOVERED IN MEDICAL AIR LINE OUTLET WHEN VENTILATOR ALARMED. THERE WAS NO APPARENT INJURY TO VENTILATOR DEPENDENT PT'S BECAUSE ALL WERE IMMEDIATELY SWITCHED TO INDEPENDENT AIR SUPPLY SYSTEMS. FURTHER INVESTIGATION FOUND THAT A BLOW DOWN VALVE ON THE IN LINE REFRIGERATED AIR DRYER HAD MALFUNCTIONED ALLOWING A BUILD UP OF WATER IN THE LINE. FAILURE TO FOLLOW UP ON THE REPAIR OF A MALFUNCTIONING DEWPOINT MONITOR ALARM ALSO CONTRIBUTED TO THE EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HANKISON REFRIGERATED COMPRESSED AIR DRYER BTI HANKINSON 80200 *

Patients

Seq Age Sex Outcome Treatment
1 * Required Intervention FILTER UNITS-HANKISON 1 MICRON MOD T400-16M-5L| SN 1317-5-9506-113,| MODEL DPS-100 SN 0103, SENSOR SN196| COMPRESSORS-PUMP SKID-2 NASH MOD OC6B,| SN 9205,| COMPRESSORS-SKID SN 3-7691,| HANKINSON 0.1 MICRON MOD A550-24-8G