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

Model Number V60 VENT, CHINA OPT: CFLEX, AVAPS

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Dyspnea (1816); Wheezing (4463)

Event Date 12/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

The customer alleged that after repeated adjustment of ventilator parameters, the tidal volume problem could not be improved.The treatment effect was poor and vital signs were unstable.The device was in clinical and therapeutic use at the time of the event in question.The sequence of events was reported as follows: the patient of unknown age and gender was admitted to the hospital due to acute onset of chronic obstructive pulmonary disease (copd).The institutional physician recommended treatment which included v60 ventilator (software version 2.10), unspecified anti-infective and anti-asthmatic, and nutritional support.After several days of treatment, on (b)(6) 2021 the patient experienced evident wheezing, dyspnea, and low tidal volume.Peripheral oxygen saturation (spo2) at the time of the event was not reported.Repeated adjustment of ventilator parameters did not improve the low tidal volume.The patient reportedly had poor treatment effect and had unstable vital signs (values unspecified).As a corrective action, the v60 device was replaced with another ventilator of the same model for auxiliary ventilation.The events did not require further medical intervention.There was no delay in treatment.Subsequently, the patient¿s tidal volume reached the normal range, and the spo2 was more than 90%.The device was evaluated and repaired by the institution¿s third-party maintenance service.It is unknown if parts were replaced, but the device has been placed back into service.Philips was not able to confirm the reported malfunction as the device was repaired by a third party and no diagnostic reports (drpt) were available.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 13638186
• MDR Text Key: 288191502
• Report Number: 2031642-2022-00551
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: 00884838025776
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

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 VENT, CHINA OPT: CFLEX, AVAPS
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 03/01/2022
• Date Device Manufactured: 10/21/2016
• 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
• Patient Outcome(s): Required Intervention