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

Model Number V60

Device Problems Improper Flow or Infusion (2954); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 03/23/2020.

Event Description

It was reported that the unit's blower was making a humming noise and not blowing properly.The device was in use at the time of the event; however, there was no patient harm.The patient was transferred to another unit to resume therapy.The manufacturer's remote service technician performed troubleshooting with the customer.The technician provided the customer with part information for a replacement blower.

Manufacturer Narrative

G4: 20may2020.B4: 21may2020.H11: b1 and h1 updated: there was no harm to the patient as a result of swapping the ventilator; therefore, this complaint is not a serious injury event.H10: the customer replaced the blower and the issue was resolved.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: 23mar2020; b4: 03apr2020.Additional information received from the customer that the unit also declared a low pressure alarm.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: 27jun2020 b4: (b)(6)2020 blower motor assembly was returned to failure investigation for analysis.Visual inspection of the blower assembly revealed no evidence of damage or contamination the blowers end cap was removed and impeller inspected there were signs of impeller rubbing the motor housing.The determination could be made that the device failed to meet specifications, the blower motor impeller rubbing against the blower housing made the blower noisy.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: 9868260
• MDR Text Key: 187682726
• Report Number: 2031642-2020-00998
• 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: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.