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

Model Number V60

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Renal Failure (2041); Urinary Retention (2119)

Event Type  Death  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 22feb2021.

Event Description

Following a ventilator change, philips was notified of a patient death due to acute renal failure secondary to urinary retention while on a secondary v60 ventilator.The device was in clinical use and providing therapy to the patient at the time of the event.No allegation of cause or contribution of the v60 ventilator has been made in relation to the patient expiration.

Manufacturer Narrative

G4: (b)(6) 2021.B4: (b)(6) 2021.Further information provided by the reporter revealed initiation date of therapy on the v60 ventilator (b)(6), as (b)(6) 2020.No harm, injury, or allegation of malfunction was noted during therapy duration with cessation of positive pressure ventilation occurring on (b)(6) 2021.It was noted that approximately 18 days after the termination of positive pressure therapy via the v60 ventilator, the patient expired with a primary cause of uremia due to acute renal failure.Due to absence of allegation or malfunction of the v60 ventilator, no device evaluation has been requested by the reporter or customer.Based upon the information provided by the reporter and customer, no allegation of malfunction or failure to meet manufacturer declared specifications was found.The v60 ventilator was not in clinical or therapeutic use on a patient during the time of the patient expiration.No causal or contributory relationship has been alleged or found between the device performance and patient death.The root cause has been determined to be patient condition related with the primary cause of uremia due to acute renal failure resulting in the patient death.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
• MDR Report Key: 11361085
• MDR Text Key: 232926209
• Report Number: 2031642-2021-00685
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2020
• 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 PATIENT CIRCUIT, MASK, AND HUMIDIFIER; UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Death