DISPOSABLE SENSOR 572

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-05-10 for DISPOSABLE SENSOR 572 manufactured by Criticare Systems, Inc..

Event Text Entries

[15618507] Six month old male was being monitored at home for oxygen saturation on a cricicare systems poet monitor with a disposable sensor. We were notified by the attending nurse at approx. 12:30 pm on 2/9/93 that the pulse oximeter portion did not seem to be functioning properly. The nurse requested we schedule a visit at 2:30 due to the act that the child was napping. A respiratory therapist was dispatched to the patient's home at 2:30 to trouble shoot the machine. He removed the disposable pulse oximeter sensor from the child's left big toe and noticed what appeared to be a blackened type of burn area. The therapist immediately called his supervisor who went to the patient's home at 3:30p. M.. The poet monitor and the sensor involved were removed from the home. The disposable pulse oximeter sensor was sent via federal express to manufacturer. It was reported the next day that this particular sensor had malfunctioned due to an electrolysis process. The patient was seen at a hospital by a plastic surgeon resident. The patient's parents were told that the child's wound would heal in approximately two to three weeks. We are waiting for a written report from the physician about the findings on this incidentinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. 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: electrical tests performed. Results of evaluation: electrical problem. Conclusion: device failure occurred and was related to event, device failure related to patient condition, device failure directly contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 33638-1993-09001
• MDR Report Key: 5611
• Date Received: 1993-05-10
• Date of Report: 1993-02-17
• Date of Event: 1993-02-09
• Date Facility Aware: 1993-02-09
• Report Date: 1993-02-17
• Date Reported to Mfgr: 1993-02-17
• Date Added to Maude: 1993-07-16
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• 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: DISPOSABLE SENSOR
• Product Code: KXN
• Date Received: 1993-05-10
• Model Number: 572
• Lot Number: R1290
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 5310
• Manufacturer: CRITICARE SYSTEMS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-05-10