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 Intermittent Loss of Power (4016)

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

Event Date 09/08/2022

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that when the ventilator is in use, the alternating current will be automatically disconnected.The customer alleges that this is a product quality problem.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user noted.There was a delay in therapy due to the intermittent problem but no reported medical intervention necessary.The investigation is ongoing.

Manufacturer Narrative

Reporting institution phone number -(b)(6).Reporter phone number - (b)(6).

Manufacturer Narrative

H10: the field service engineer (fse) stated in a good faith effort (gfe) response received on 11/23/2022 that the device was switching to battery automatically while using ac power.The device was reported to be in use at the time of the reported problem.The customer reported that there was no adverse outcome.The fse confirmed that there was no patient harm as a result of the product issue.The fse also stated that onsite service was conducted, but the customer refused to pay for the part and repair.The customer did not have any further feedback following onsite service troubleshooting and information provision.No further work was performed by philips.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 15756970
• MDR Text Key: 307683942
• Report Number: 2031642-2022-02788
• 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,Followup

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
• 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
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 12/15/2022
• 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