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

Model Number V60

Device Problem Disconnection (1171)

Patient Problems Death (1802); Pneumonia (2011)

Event Date 11/10/2017

Event Type  Death  

Manufacturer Narrative

(b)(6).Udi: (b)(4).The customer reported that a patient on a v60 ventilator passed away after the mask became disconnected from the patient.The ventilator audibly alarmed, however, the nurse did not notice that the mask had come off the patient until approximately ten minutes later.The ventilator was evaluated by philips and no abnormality was found.The ventilator error logs were reviewed and no hardware issues were found.The unit was returned to service and will not be returned.

Event Description

The customer reported that a patient with pneumonia on a v60 ventilator passed away after the mask became disconnected from the patient.

• 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
• Manufacturer (Section G): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: lisa cardenas ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 7739031
• MDR Text Key: 115684072
• Report Number: 2031642-2018-01526
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN MASK AND CIRCUIT.
• Patient Outcome(s): Death
• Patient Age: 74 YR