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 Volume Accuracy Problem (1675)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

Reporting address line 1: (b)(6).Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporter phone #: (b)(6).

Event Description

The customer reported a ventilator experienced a low tidal volume.The device was in clinical use at the time the issue was discovered.There was no patient or user harm reported.The device was evaluated by the customer and a philips remote service engineer (rse).Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

H10: the customer reported a ventilator experienced a low tidal volume during testing.The device was not in clinical use at the time the issue was discovered.There was no patient or user harm reported.The remote service engineer (rse) reported that it was found that there was a gas leak in the pipeline, therefore, the customer replaced the pipeline from their own store.The unit was then reported to be functioning back to normal.

• 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: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 15242038
• MDR Text Key: 302712278
• Report Number: 2031642-2022-02162
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: (01)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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 VENT, CHINA OPT: CFLEX, AVAPS
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2022
• Date Device Manufactured: 05/04/2017
• 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