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

Model Number V60

Device Problems No Audible Alarm (1019); Unexpected Shutdown (4019)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 11jul2020.

Event Description

The customer reports that the unit was in use when the vent shutdown.No alarms noted, machine just turned off.Patient needed intervention as her saturations had dropped to 77% and would not increase despite being placed on another bipap unit.Patient was given an albuterol nebulizer treatment and placed on a nrb mask.Patient remained on nrb for 15 minutes until saturations returned to normal.Then place on bipap with increased settings to maintain saturations in the low 90¿s.The customer reported that the unit was in use on patient, but there was no patient harm reported.The customer contacted product support and requested for service repair.

Manufacturer Narrative

G4: 16sep2020.B4: 18sep2020.This reporter stated that a 68 years old female patient with a height of 1.57 meters and a weight of 117 kilograms, was admitted to a hospital on an unknown date, with admitting diagnoses of respiratory failure, chronic obstructive pulmonary disease (copd) exacerbation, congestive heart failure (chf) exacerbation, sepsis, hypoxia, and pneumonia.Relevant medical history included chf, copd, and type 2 diabetes mellitus; diagnostic dates not reported.Relevant concomitant medical products included albuterol, levalbuterol, and ipratroprium bromide via inhalation route; drug dosing and frequency was not reported.No relevant past drug history was reported.While admitted on an unknown date, the patient was prescribed non-invasive ventilation therapy via the respironics v60 ventilator, fisher & paykel rt 219 22millimeter circuit, and fisher & paykel respiratory humidifier mr850jhu; lot numbers and expiration dates were not reported.Device settings and prescription included spontaneous timed mode, inspiratory positive airway pressure of 16cmh20, expiratory positive airway pressure of 10 cmh20, respiratory rate of 10 breaths per minute (bpm), and fraction of inspired oxygen of 100%.Alarms settings of the device included high rate of 20 bpm, high pressure of 20 cmh20, low pressure of 2 cmh20, apnea 20 second delay.While admitted on (b)(6) 2020 at 0530, the patient was receiving bi-level positive airway pressure (bipap) therapy via the v60 device, the patient¿s peripheral capillary oxygen saturation (spo2) was in the high 90¿s, the patient experienced an event of diminished breaths sounds, the ventilator shut down with no alarms generated and would not turn back on, the patient¿s oxygen saturation dropped to 77%, the patient was placed on another bipap unit; brand and model not reported, the event of oxygen desaturation did not resolve, the patient was then administered albuterol nebulizer treatment via inhalation route; dosing and frequency not reported, was then placed on a non-rebreather mask; liters per minute not reported, for 15 minutes when oxygen saturation levels returned to normal, and then the patient was placed on a bipap unit; brand and model not reported, with increased settings to maintain oxygen saturation in the low 90¿s.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: 22jul2020 b4: (b)(6) 2020.The bench service engineer evaluated the unit and confirmed the complaint.The unit is showing error code machine, and proximal pressure sensors failed on boot up.After troubleshooting, it was found that when the da pcba to mc pcba cable moves around, the connection is intermittent and will cause the error.The bench service engineer replaced data acquisition (da) pcba to motor controller (mc) pcba cable to address the reported problem.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

The data acquisition pcba to motor controller pcba cable was returned to philips california's failure investigation laboratory.Visual inspection of the data acquisition pcba to motor controller pcba cable revealed no evidence of damage or contamination.The data acquisition pcba to motor controller pcba cable was tested and no failures were identified.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 10261791
• MDR Text Key: 198479201
• Report Number: 2031642-2020-02317
• 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,Followup,Followup
• Report Date: 08/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2020
• Is this an Adverse Event Report?: Yes
• 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: 05/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 116