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

Model Number V60

Device Problem Loss of Power (1475)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.(b)(6) 2020.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.

Event Description

It was reported to philips that the device shut down while in use.There was no noted error code at the time of the event/full power failure.It was communicated to the respiratory director that there was no audible alarm sounding at the time of the event.The device was in use at the time of the event.The patient was in a room with closed doors and the registered nurse (rn) responded to the patient when they noted bradycardia and desaturation on the cardiac monitor in the room.The patient was manually ventilated and intubated/placed on drager ventilator.

Manufacturer Narrative

On (b)(6) 2020, diagnostic report (drpt) generated error code 1127 (opv circuit failed).The device was applied clinically during the time of the event, providing cpap (continuous positive airway pressure) therapy to the patient.It was stated by the reporter that during power on of the device, several alarms triggered and displayed visually on the gui (graphic user interface).The alarms were bypassed and therapy was initiated upon the patient.The patient was observed to maintain stable spo2 (peripheral capillary oxygen saturation) with device functionality noted with no malfunction.After performing checks on a different patient, the clinician returned to bedside due to alerts provided by an external monitor (unspecified) of spo2 decrease (unspecified degree).Upon arrival bedside, the clinician stated that the patient had removed his non-invasive interface himself and that the prior alarms that had been cleared upon initiation of therapy had reappeared and the device was inoperative.The clinician noted the device gui was black with white text displayed alerting the user of the inoperative condition.The patient was placed on supplemental oxygen (delivery method and fio2 unspecified) while the clinician retrieved a backup ventilator.Further correspondence with the device distributor noted that repair of the device was required with subsequent orders for replacement parts (unspecified) to be placed.The distributor has since requested that the complaint record be closed with no further information divulged.Based upon the information provided, further investigation into the root cause of the alleged malfunction could not be determined.The device was in clinical and therapeutic use at the time of the event with cause and contribution to the patient outcome noted.

• 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): PHILIPS MEDICAL SYSTEMS; carlsbad CA
• Manufacturer Contact: bill cole ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11021329
• MDR Text Key: 221829046
• Report Number: 2031642-2020-04580
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

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 Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2016
• 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