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

Model Number	V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: insufficient information is available to determine the resolution of the event.The customer was provided with the parts id; however, it could not be confirmed if the customer replaced the specified parts.Multiple good faith efforts were made to retrieve device evaluation, repair, and operational status on (b)(6) 2023, (b)(6) 2023 and (b)(6) 2023, however, yielded no response from the customer.It is unknown if any parts or repairs have been conducted.The complaint will be processed for closure.If additional information is received at a later date, the complaint will be reopened, and a supplemental report will be submitted.H11: updated contact information, contact office entity, and manufacturing site.This report is being submitted as part of a corrective action to replace manufacturer report # 2031642-2023-00336.All information from the original report(s) has been transferred to this report.
Event or Problem Description
Philips received a complaint from the customer, reporting that the v60 ventilator had a co2 rebreathing risk error.The device was in clinical use when the issue occurred.No patient or user harm was reported.The remote service engineer (rse) noted that the customer has a v60 ventilator that has a co2 rebreathing issues.The customer verified that there was an error code 1201 and 1203 in the history event log.The customer also stated that the average air display was reading 1.6 slpm, even though the device was set to 0.The rse recommended replacing the flow sensor assembly or gas delivery system.The customer was provided with the part ids in order to purchase replacement parts.

• Brand Name: RESPIRONICS
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17434095
• Report Number: 2518422-2023-17743
• Device Sequence Number: 12471234
• Product Code: MNT
• UDI-Device Identifier: 00884838025738
• UDI-Public: 00884838025738
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+
• Device Catalogue Number: U1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 08/01/2023
• Date Device Manufactured: 10/06/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown