MAUDE Adverse Event Report: RESPIRONICS, INC. AF531; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	00
Health Effect - Clinical Codes	Cyanosis (1798); Low Oxygen Saturation (2477)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A patient arrived to the emergency center in pending respiratory failure.Spo2 83% while on a nrb with very labored breathing.The physician ordered bipap to be started.Respiratory therapist was preparing to use an 840 vent which requires that the elbow attachment on the mask be exchanged with respironics product ref: 1043210.The elbow currently on the mask could not be removed at all.Another mask was retrieved and once again, that elbow could not be removed.In the process of trying to remove the elbow from the second mask, the elbow holder physically broke off of the mask.There was a long delay of care and the patient further desaturated to 75% and became cyanotic.A third mask functioned normally and the patient was able to be placed on bipap with improved saturation, color, and wob.The total delay time was 30 minutes.Upon further investigation by the clinical engineering department, it was noted by the respiratory therapists that several masks had elbow attachments that could not be removed.17 masks in total were collected, including the 2 masks from this event.All masks were part of 3 lot numbers.Per site reporter: the sales rep will file a complaint report and exchange the effected masks.

• Brand Name: AF531
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 6947505
• Report Number: 6947505
• Device Sequence Number: 19134821
• Product Code: CBK
• UDI-Device Identifier: 00606959004566
• UDI-Public: (01)00606959004566
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2017
• Report Date (Section F): 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00
• Device Catalogue Number: 1119007
• Device Lot Number: 170524
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 80
• Date Report Sent to FDA: 10/03/2017