MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 PRO; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number AUX3100S19

Device Problems Noise, Audible (3273); Unexpected Shutdown (4019)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging a device gave auditory tone and then stopped while in use.There was no harm or injury reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The bipap a40 pro, model# aux3100s19 is substantially similar to the bipap a40, model# 1111169 and will be reported in the united states under bipap a40 pro, 501k number: 121623.H3 other text : device not returned to the manufacturer.

Manufacturer Narrative

Previously report: the manufacturer received information alleging a device gave auditory tone and then stopped while in use.There was no harm or injury reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.New information: the device evaluation is still pending but the following high priority alarm error codes were noted in the device event log: 39 (low min vent), 42 (apnea), 43 (circuit disconnect) only if there is a failure and 67 (soft power loss).The manufacturer's investigation is ongoing.A final report is being submitted at this time.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

Previously report: the manufacturer received information alleging a device gave auditory tone and then stopped while in use.There was no harm or injury reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.The device evaluation is still pending but the following high priority alarm error codes were noted in the device event log: 39 (low min vent), 42 (apnea), 43 (circuit disconnect) only if there is a failure and 67 (soft power loss).The manufacturer's investigation is ongoing.A final report is being submitted at this time.If any additional information is received, a follow up report will be filed.New information: the ventilator was returned to the philips investigation lab (pil) for evaluation and the customer¿s complaint was not confirmed.The device was visually inspected and there was nothing to note.The device error logs were reviewed and noted on (b)(6) 2023 the unit went into sleep mode and the device was not powered up until (b)(6) 2023.At the time of entering sleep mode the detachable battery was the power source and the capacity is recorded as 97%.The unit seems not to be in use on the reported incident date.The unit performed as expected at the investigation lab.The device was scrapped.

• Brand Name: BIPAP A40 PRO
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18243464
• MDR Text Key: 329593687
• Report Number: 2518422-2023-32755
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00606959059177
• UDI-Public: 00606959059177
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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: Lay User/Patient
• Device Model Number: AUX3100S19
• Device Catalogue Number: AUX3100S19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 02/15/2024; 05/23/2024
• Supplement Dates FDA Received: 02/29/2024; 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1