MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problems Device Alarm System (1012); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.

Event Description

The customer reported a primary alarm failure.The ventilator was being used on a patient at the time of the reported event, however, there was no patient harm.The patient's information could not be disclosed.There was no medical intervention required as a result of this event as the unit was able to be used continuously.The manufacturer¿s international service technician evaluated the ventilator and confirmed the occurrence of the primary alarm failure diagnostic code.The speakers will be replaced once the customer approves the repair.

Manufacturer Narrative

G4: 08oct2020, b4: 12oct2020.Failure analysis on the returned 2 speakers shows that the two speaker's assembly was tested, and no failures were identified.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

G4: 13jul2020.B4: 14jul2020.The service technician reported that the primary alarm failed was not duplicated.The service technician replaced the speaker#1 and speaker#2 to prevent recurrence.Unit was checked overall, cleaned, run in tests and functionally tested.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

G4: 25jun2020 b4: (b)(6)2020 service technician stated that the customer was contacted and urge to respond but since there had been no response, the case was closed.A supplemental report will be submitted if new information is received.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 9953758
• MDR Text Key: 188269742
• Report Number: 2031642-2020-01297
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2020

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: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 03/24/2020; 03/24/2020; 03/24/2020
• Supplement Dates FDA Received: 07/06/2020; 07/14/2020; 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER