PNEUPAC VRI AHA VENTILATOR WITH REGULATOR AND CIRC

Additional Manufacturer Narrative

OTHER TEXT: ADDITIONAL INFORMATION IS PROVIDED IN H.2., H.3., AND H.6. FUNCTIONAL TESTING DID NOT CONFIRM THE CUSTOMER'S COMPLAINT. THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE PRODUCT IS BEYOND A YEAR FROM MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DHR REVIEW WAS NOT PERFORMED. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FOR ALL ENQUIRIES OR FOLLOW-UP QUESTIONS RELATED TO THE RECORD, DO NOT USE REGULATORY.RESPONSES@SMITHS-MEDICAL.COM LOCATED IN SECTIONS G.1., PLEASE DIRECT THOSE TO THE FOLLOWING: REGULATORY.RESPONSES@ICUMED.COM. D.4. FULL UDI NUMBER: (B)(4).

Additional Manufacturer Narrative

OTHER TEXT: B3: DATE OF EVENT, D4: UDI SECTION UNKNOWN, AND G5: 510K ARE UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE WILL NOT CYCLE AND NEEDS PREVENTIVE MAINTENANCE. PATIENT INVOLVEMENT IS UNKNOWN.