MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2021

Event Type  malfunction  

Event Description

It was reported that the ventilators blower stalled.There was no patient involvement.The customer troubleshot with technical support and found in the device diagnostic logs error code blower stalled, then set the pressure to 1 and noted that the blower revolutions per minute (rpm) goes to 3000.The customer noted a brown residue in the blower.Upon a follow up the customer noted that the blower boots, internal hoses were discolored, and the gas outlet is clear.The customer was advised to replace the blower, tubing, and rubber boot kit.Further information is pending.

Manufacturer Narrative

Multiple attempts were made to obtain information regarding the repair and operational status with no response from the reporter and cannot be determined.If additional information is later obtained, a supplemental report will be submitted.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12697951
• MDR Text Key: 278382217
• Report Number: 2031642-2021-05379
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 12/15/2021
• Date Device Manufactured: 12/11/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1