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

Model Number V60

Device Problem Erratic or Intermittent Display (1182)

Patient Problems Death (1802); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 14mar2019.The philips field service engineer confirmed the nav-ring was not responding but was not able to duplicate the reported ipap issue.No additional patient detail has been provided by the customer despite attempts to obtain the information.

Event Description

The customer reported that while in patient use on a v60 ventilator the ipap setting was jumping from 15 to 40, the patient vomited in the mask and later passed away.The customer reported that the patient passed away.No additional patient detail has been provided by the customer despite attempts to obtain the information the customer reported that the patient passed away.No additional patient detail has been provided by the customer despite attempts to obtain the information.Event date not specified; estimate used.

Manufacturer Narrative

Date of report: 13may2019.Date received by manufacturer: 26apr2019.The philips failure investigation technician performed an evaluation of the switch printed circuit board assembly and nav-ring¿s accept button and no failures were identified.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 philips failure investigation technician performed a visual inspection of the user interface (ui) front bezel assembly that revealed no evidence of damage or contamination.Further examination revealed that contamination buildup was found on the rotary adjustment assembly (nav ring) matrix that causes the nav ring to be unresponsive.The ui front bezel assembly with the new nav ring production process will be tested for the root cause of the rotary adjustment assembly (nav ring) failure.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

Mfr rec'd date: 26mar2020.Report date: 26mar2020.Clinical review of the complaint and device investigation has been completed and determined the device malfunction presents possibility of serious injury and therefore meets reportability criteria.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: 18feb2020 b4: (b)(6)2020.The manufacturer has assessed a patient death based upon received information regarding a 92 year-old female patient.Patient's primary residence is in skilled nursing facility, with the following disclosed medical history and diagnosis: cardiac disease (atrial fibrillation), a recent hip replacement, dementia, hypertension, and kidney disease.After several days of exhibited cough the patient developed shortness of breath.The patient was taken to the emergency department at 0410 on 02/17/2019.The patient presented to the emergency department with hypoxemia (spo2 88%), an elevated leukocyte count, and very low potassium.She was treated with positive pressure ventilation, "cpap" according to one note and "bipap" according to another note.By 0430 the patient had experienced nausea and subsequent emesis.At this time the patient was transitioned from "bipap" therapy to a non-rebreather mask, maintaining spo2 values of 97%.The patient was alert and oriented according to her family members, who requested transfer to a hospital which had cardiology services, at approximately 0530.The patient had multiple chronic illnesses, was admitted with pneumonia, vomited in the ed, and was in satisfactory condition post-emesis to allow transfer to another hospital.There is no compelling evidence for aspiration.The patient expired following transfer.Based on this information, philips' internal medical expert concluded that the patient's death was most likely due to complications from pneumonia and co-morbidities with which she was admitted to the emergency department.The patient was also at risk of pulmonary embolism due to her recent hip operation.Consequently, it is unlikely that the bipap settings caused the patient's emesis or contributed in any significant way to the patient's ultimate 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
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 8420935
• MDR Text Key: 138813466
• Report Number: 2031642-2019-01493
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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,user faci
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/18/2019

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: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 02/18/2019; 02/18/2019; 02/18/2020; 02/18/2020
• Supplement Dates FDA Received: 04/04/2019; 05/13/2019; 03/17/2020; 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT CIRCUIT, MASK, HUMIDIFIER: UNKNOWN; PATIENT CIRCUIT, MASK, HUMIDIFIER: UNKNOWN
• Patient Outcome(s): Death
• Patient Age: 92 YR