FISHER-PAYKEL TEMPERATURE PROBE 900MR560

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 FISHER-PAYKEL TEMPERATURE PROBE 900MR560 manufactured by Fisher-paykel (distributed By Baxter).

Event Text Entries

[807] A fisher paykel temperature probe normally attached to a fisher paykel humidifier was found to be dislodged causing a leak in the patient's ventilator circuit. This leak disrupted the airflow to the patient causing the patient to go into respiratory arrest. The puritan bennett ventilator alarmed, staff responded and resuscitated the patient. The cause for the temperture probe being dislodged is unknown. Temperature probes on other humidifiers were checked for correct fittingsinvalid data - regarding single use labeling of device. 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: a device from same lot was evaluated, mechanical tests performed, visual examination. Results of evaluation: none or unknown. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: yes. Corrective actions: user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 278
• MDR Report Key: 278
• Date Received: 1992-03-05
• Date of Report: 1992-02-24
• Date of Event: 1991-11-28
• Date Facility Aware: 1992-02-17
• Report Date: 1992-02-24
• Date Reported to FDA: 1992-02-24
• Date Reported to Mfgr: 1992-02-24
• Date Added to Maude: 1992-04-15
• 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: FISHER-PAYKEL TEMPERATURE PROBE
• Generic Name: UNKNOWN
• Product Code: HCS
• Date Received: 1992-03-05
• Model Number: 900MR560
• Catalog Number: 900MR560
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 273
• Manufacturer: FISHER-PAYKEL (DISTRIBUTED BY BAXTER)

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-03-05