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

Model Number 1137276

Device Problem Gas Output Problem (1266)

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

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer's biomedical engineer reported a 'venti fail' message showing an error' cbito2 device failed.It is unknown if there's patient involvement.The remote service engineer indicated a possible fault with the o2 valve or the da pca.A service quote for bench repair will be provided to the customer.

Manufacturer Narrative

H10: upon further investigation, this report was determined to be a duplicate of the issue reported under mfr report number 2031642-2022-02191.The investigation and all reporting activities will be documented under mfr report number 2031642-2022-02191.Therefore, this complaint no longer meets reportability requirements.

• 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: 15666797
• MDR Text Key: 306599480
• Report Number: 2031642-2022-02621
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838089280
• UDI-Public: (01)00884838089280
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,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: 1137276
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 01/09/2023
• Date Device Manufactured: 02/08/2019
• 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