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

Model Number V60

Device Problem Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

The international philips field service engineer reported a ventilator required a spare part being out of order.As a result, a battery part was ordered.Patient or user involvement information is unknown and was requested from the customer.There was no patient or user harm reported.The device was evaluated by the fse, who confirmed the reported issue.The philips international field service engineer (fse) replaced the battery.The unit was functionally tested and successfully passed all testing.The unit was returned to service.No other anomaly was reported.

Manufacturer Narrative

Reporting address city: (b)(6).Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporting institution phone # (b)(6).Reporter phone # (b)(6).

Manufacturer Narrative

Patient or user involvement information is unknown and was requested from the international philips field service engineer (fse).The fse did not respond.No patient or user harm was reported.

• 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: 13114337
• MDR Text Key: 287930928
• Report Number: 2031642-2021-05903
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: 00884838009851
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 02/14/2022
• Date Device Manufactured: 10/26/2018
• 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