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

Model Number V60

Device Problem Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 01jul2020.

Event Description

The customer reported the cart is not attached to the unit.The device was reported to be in clinical use at the time the reported issue was discovered; however, there was no reported patient or user harm.

Manufacturer Narrative

G4: 25aug2020.B4: 28aug2020.It was confirmed that the device was not in patient use at the time the reported issue was discovered.There was no reported patient or user harm.It was reported that the ventilator in question was moved between two departments.Upon arrival in the new department, it was noticed that it was not well fixed to the stand.At that point the ventilator was disconnected from the cart.It was reported that the unit was later put into use, possibly leaning against a wall unit.The cart instead was put into storage awaiting repair.The customer requested to replace the fastenings to the cart that, after several years, did not seem fully stable.When the correct spare part was ordered, the manufacturer's field service engineer (fse) went to the customer site.The fse was not authorized to enter the department to evaluate the device due to access restrictions following codiv-19 cases.The fse handed the screws to the hospital's engineering technicians.The hospital's engineering technicians, who had permission to enter the site, mounted them with the manufacturer¿s fse's instructions.The customer reported that they tested everything, and confirmed that the device works correctly.While this cart issue was detected prior to patient use, it is noted that the v60 may have been put into use without the cart, possibly leaning against a wall unit.Putting the device in use without a cart and leaning against a wall unit is considered user-error and off label use of the device.Per the v60 user guide, during intra-facility patient transporting, the device is only intended to be used with a cart to move the ventilator.Per the v60 user guide, to ensure normal air circulation and exchange, it is noted to not cover or block the ports on the ventilator.It is noted to not block the air inlet panel on the right side of the ventilator, and not cover or position the ventilator so as to adversely affect its operation or performance.It is noted to use the unit in an upright position that does not block the air inlet.To reduce the risk of the device overheating and possible burn injury, it is noted to not block the fan intake at the rear of the ventilator.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: 10221109
• MDR Text Key: 197756627
• Report Number: 2031642-2020-02256
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.