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

Model Number V60

Device Problem Failure to Charge (1085)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 11jun2020.

Event Description

The battery went below 12 volts and would not charge.The device was in use with a patient via non invasive facemask at the time of the event.When the unit stopped ventilating the mask was removed from the patient and the patient was placed on oxygen, but no patient harm was reported.The manufacturer's field service engineer determined the battery needs to be changed.The internal battery was replaced and the issue was resolved.

Manufacturer Narrative

G4: 09jul2020 b4: (b)(6)2020.Upon investigation it was determined that this complaint is a duplicate of an existing complaint, for which mfr report # 2031642-2020-02063 was submitted.During review, it was determined that the battery failure submitted in mfr#2031642-2020-02068 was a result of the failure found in mfr report# 2031642-2020-02063.All repair information is captured in the actual complaint, mfr# 2031642-2020-02063.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: 10146654
• MDR Text Key: 195227815
• Report Number: 2031642-2020-02068
• 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
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• 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: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER