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

Model Number V60 V60PLUS VENTILATOR

Device Problem Communication or Transmission Problem (2896)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating that a spi bus failure occurred-- the following error codes were present: 1113, 110f, 110e, 1110, 1107, 1106.At this time, it is unknown if there was patient involvement at the time the issue was discovered; however, there was no reported harm to the patient or user.The customer called technical support to report that a spi bus failure occurred-- the following error codes were present: 1113, 110f, 110e, 1110, 1107, 1106.The field service engineer (fse) did not evaluate or repair the device as the issue was no longer occurring.The customer canceled onsite service, so no work order (wo) was generated.The investigation is ongoing.

Manufacturer Narrative

H10: there was no patient involvement at the time the issue was discovered as the issue occurred while an equipment management service and repair (emsar) service representative was attempting a field change.The biomedical engineer (bme) called technical support to report that a spi bus failure occurred-- the following error codes were present: 1113, 110f, 110e, 1110, 1107, 1106.The field service engineer (fse) did not evaluate or repair the device as the issue was no longer occurring.The bme canceled onsite service, so no work order (wo) was generated.Per good faith effort (gfe) response received 25mar2024, the bme stated that the device was repaired in-house by replacing the flow sensor assembly.The bme confirmed that the issue was resolved after verifying proper calibration and operation.The device passed the required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.Although requested, the defective parts were not received at this time.A supplemental report will be submitted if the part is received and evaluated.

• Brand Name: RESPIRONICS
• Type of Device: 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18923971
• MDR Text Key: 337903371
• Report Number: 2518422-2024-14174
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/28/2024
• Date Device Manufactured: 07/10/2013
• 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