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

Model Number V60

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2018.Date of report: 09/06/2018.The philip's field service engineer (fse) verified the reported problem.The fse checked the connection from the inlet and the power supply and found that the connection was loose.The fse reconnected and secure the cable to address the reported problem.Patient information was requested from the customer, but no response was received.

Event Description

The customer reported that the ventilator remained on direct current power after connecting to alternate current power.The customer reported that the unit was in use on patient , but there was no patient harm reported.The event date was not specified; estimate used.

Manufacturer Narrative

Date of report: 26nov2018.Date of manuafacturer: 16nov2018.Failure analysis on the returned power cord shows that the customer complaint of ¿no ac power.¿ was confirmed.The alternating current plug was damaged.

• 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: 7857610
• MDR Text Key: 119658613
• Report Number: 2031642-2018-01824
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

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: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 08/14/2018
• Supplement Dates FDA Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT MASK AND CIRCUIT: UNKNOWN