TRIPLE KIT - (CUSTOM TRANSDUCER KIT) SPECIAL ORDER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-03-05 for TRIPLE KIT - (CUSTOM TRANSDUCER KIT) SPECIAL ORDER manufactured by Viggo Spectramed.

Event Text Entries

[19879810] Triple transducer changed at 0900 on 16 february 1992. At 1200 on 16 february 1992 fluid noted to drip continuously per flush bag of heparin. Trouble shooting done and arterial line "flush" mechanisms functioning appropriately. Questionable faulty rubber stopper in valve in transducer housingdevice labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, actual device involved in incident was evaluated, actual device involved in incident was evaluated, other, other. Results of evaluation: invalid data. Conclusion: device failed during assembly, device failed just prior to use. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor, invalid data. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 274
• MDR Report Key: 274
• Date Received: 1992-03-05
• Date of Report: 1992-02-20
• Date of Event: 1992-02-16
• Date Facility Aware: 1992-02-16
• Report Date: 1992-02-20
• Date Reported to FDA: 1992-02-20
• Date Reported to Mfgr: 1992-02-18
• Date Added to Maude: 1992-04-14
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TRIPLE KIT - (CUSTOM TRANSDUCER KIT)
• Generic Name: TRIPLE PRESURE MONITORING KIT
• Product Code: CAP
• Date Received: 1992-03-05
• Model Number: SPECIAL ORDER
• Lot Number: 91 NOV 033
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 270
• Manufacturer: VIGGO SPECTRAMED

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-03-05