DISPOSABLE SENSOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-09-23 for DISPOSABLE SENSOR manufactured by Criticare System, Inc..

Event Text Entries

[3700] Six month old male was being monitored at home for oxygen saturation on a criticare systems poet monitor, with dispodsable sensor. We were notified by the attending nurse at approximately 12:00 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 fact that the child was napping. A respiratory therapist employed by the distributor. Was dispatched to the patient's home at 2:30 to trouble shoot the machine. He removed the disposable pulse oximeter from the child left big toe and noticed what appeared to be a blackened type of burn area. The therapist immediately called his supervisor. The supervisor and another person went to the patient's home at approximately 3:30 pm. The poet monitor and the sensor involved were removed from the home. The disposable oximeter was sent to the manufacturer via federal express. The findings were that this particular sensor had malfunctioned due to an electrolysis process. The patient was seen at a hospital by a plastic surgeon. The patient's wound is expected to heal in approximately two to three weeks. We are currently waiting for a written report from the physician about findings on this incident. Invalid data - regarding single use labeling of device. Patient medical status prior to event: fair condition. Invalid data - regarding 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: actual device involved in incident was evaluated. Results of evaluation: component failure, electrical problem. Conclusion: device failure occurred and was related to event, device failure directly caused 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: 33638-1993-09003
• MDR Report Key: 6685
• Date Received: 1993-09-23
• Date of Report: 1993-07-14
• Date of Event: 1993-02-09
• Report Date: 1993-07-14
• Date Reported to FDA: 1993-07-14
• Date Added to Maude: 1993-10-07
• 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
• Generic Name: PULSE OXIMETER
• Product Code: KLK
• Date Received: 1993-09-23
• Lot Number: R1290
• ID Number: 572
• Operator: OTHER CAREGIVERS
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6369
• Manufacturer: CRITICARE SYSTEM, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-09-23