MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENT, INC NEWPORT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	E360
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	Bradycardia (1751); Low Oxygen Saturation (2477)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product not returned to manufacturer or available for evaluation.Third party engineer evaluated the device and did not find any fault.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during patient use, the e360 ventilator stopped ventilating the patient.The patient's heart rate decreased to 30 beats per minute and the spo2 (peripheral capillary oxygen saturation) was unable to be monitored.Cardiopulmonary resuscitation (cpr) was initiated immediately and the patient's heart rate recovered to 110 beats per minute with an increase in the spo2 to 99%.Additionally, it was noted patient was treated with chest compression and transferred to standby ventilator.

• Brand Name: NEWPORT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENT, INC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 8575989
• Report Number: 2023050-2019-00019
• Device Sequence Number: 16666820
• Product Code: CBK
• UDI-Device Identifier: 10884521541078
• UDI-Public: 10884521541078
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E360
• Device Catalogue Number: E360S-CN-NA
• Device Lot Number: 20111205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Weight: 45