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 |