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

Model Number V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+

Device Problem Disconnection (1171)

Patient Problems Bradycardia (1751); Hypoxia (1918); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

This report was identified by a philips representative of the post market department while checking the "medical accident information collection project 69th report" on (b)(6) 2022.The report was written as ¿as the spo2 monitor alarm sounded, a nurse visited the patient's room and found that the circuit was off the noninvasive positive pressure ventilation (nppv) mask¿.A male patient in his 70¿s who was being treated by a cardiovascular surgeon for undisclosed medical condition was on a v60 ventilator (unknown serial number, configurations, and settings) for an unknown indication.On an unspecified date in 2021, while the device was in clinical use, the oxygen saturation (spo2) monitor alarm sounded and when the nurse checked on the patient, the circuit was off the nppv mask.The type of circuit used was unknown.The nurse connected the circuit immediately, however the spo2 was unmeasurable, bradycardia was observed, and the patient did not react to a call (verbal stimuli).Thereafter, the patient passed away.Medical intervention rendered preceding the patient's death and cause of death were not reported.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

On an unspecified date in 2021, while the device was in clinical use, the oxygen saturation (spo2) monitor alarm sounded.The source of the alarm was unspecified.The type of circuit and interface at the time of the event was unknown.Upon internal review, this complaint is being downgraded from death to a product problem as there was no documentation on device failure and insufficient information to classify as a death case.No further information can be obtained as the report was identified during a retrospective review of post market data.There was no further obtainable information.

• 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: 14935511
• MDR Text Key: 295396342
• Report Number: 2031642-2022-01817
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 07/04/2022
• Supplement Dates FDA Received: 07/28/2022
• 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
• Patient Outcome(s): Death
• Patient Sex: Male