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

Model Number V60

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 21apr2020.

Event Description

The customer reported a test results error.There was no patient involvement.The manufacturer¿s international service technician evaluated the ventilator and ordered a power switch overlay, proximal kit, foot kits, top cover and battery.

Manufacturer Narrative

G4: 17jun2020.B4: 18jun2020.H11: the service technician ordered a proximal port not a proximal kit.H10: additional information was received that this ventilator used to be rented out to hospitals but it has been out of service for over 3 years.The service technician confirmed that the battery was being replaced due to its age, as it was around 5 or 6 years old and had never been replaced.Based on this information, the reported failures are unlikely to cause or contribute to death or serious injury; therefore, this complaint has been reassessed as a non-reportable event.The service technician reported that the repair was not approved and the device will not be repaired.No service was rendered.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: 30apr2020.B4: (b)(6)2020.The manufacturer¿s international service technician reported that during test and evaluation, the power switch overlay was found to be faulty.The service technician reported that the other parts need to be replaced due mechanical wear and cracks.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: 9983859
• MDR Text Key: 188809072
• Report Number: 2031642-2020-01454
• 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
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1