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

Model Number V60

Device Problems Material Discolored (1170); Device Emits Odor (1425)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 10mar2020.

Event Description

The philips service engineer (fse) identified during preventive maintenance that there was an odor and a tarnished connector.The philips service engineer (fse) confirmed the reported failure.The unit was not in clinical use at the time of the reported problem, and no patient or user was harmed.

Manufacturer Narrative

G4: 23jul2020.B4: 06aug2020.H11: b1:h1: updated: this complaint has been re-assessed.The ventilator was immediately turned off, removed from patient¿s room.No harm occurred.There was no report of medical intervention being required as a result of this event.Based on this information, the type of reported event has been updated to non-adverse event.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: 09mar2020.B4: 27mar2020.The philips service engineer (fse) replaced the cable, harness, power, v60.Fse performed all required tests per philips' manual.Unit passed all tests successfully.The unit has returned to service mode.G4: 25mar2020 b4: 27mar2020 h10: b1 and h1 updated the customer confirmed the v-60 was in operation when an electrical burning smell was noted by the registered nurse (rn).The v60 was immediately turned off and removed from patient¿s room.No patient harm occurred.Numerous attempts were made to obtain patient information but unsuccessful.If further information is obtained a supplemental report will be submitted.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: 9811377
• MDR Text Key: 190371987
• Report Number: 2031642-2020-00855
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• 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
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER