MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP PRO, INTL; NON CONTINUOUS VENTILATOR

Model Number 661P

Device Problems Degraded (1153); Fracture (1260); Material Fragmentation (1261)

Patient Problems Aspiration/Inhalation (1725); Pneumonia (2011); Pericardial Effusion (3271)

Event Date 03/01/2021

Event Type  Injury  

Event Description

Manufacturer became aware of an allegation of a user while on a bi-level positive airway pressure (bipap) device heard clicking in his tubing and a piece from the machine went into his throat and into his lungs.User developed cough and fever, went to his doctor where a ct scan was performed.User was hospitalized with pneumonia, pleural effusion and pericardial effusion for 10 days and treated with antibiotics.The radiological images did not detect a foreign body in his lungs.User was discharged home with existing symptoms of persistent cough, shortness of breath and tiredness from strenuous work.Device is no longer in use and has been sent for investigation.The manufacturer's investigation is on-going.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer received the device with humidifier for investigation.The manufacturer was unable to confirm the complaint of "piece from machine went into throat".The manufacturer does confirm there is evidence of physical damage to the device exterior (display screen is cracked and the power push wheel is broken), dirt/debris throughout the device, and liquid/water ingress causing corrosion throughout the devices, including on the humidifier lid seal, dry box seals, and on as well as under the heater plate.The devices do power up and provide flow.There were no missing components internally, nor were there any solid objects found in the blower motor assembly.The build up of corrosion, dirt and debris in the blower motor assembly and physical damage to the display screen and push wheel suggest poor maintenance by the user of the devices and not a failure of the devices under normal operation.The manufacturer concludes that no further action is necessary at this time.

• Brand Name: BIPAP PRO, INTL
• Type of Device: NON CONTINUOUS VENTILATOR
• Manufacturer (Section D): RESPIRONICS, INC.; murrysville. PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: rod mell ; 6501 living place; pittsburgh, PA 15206 ; 7243349303
• MDR Report Key: 12341375
• MDR Text Key: 267228491
• Report Number: 2518422-2021-03343
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959031180
• UDI-Public: 00606959031180
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

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: Lay User/Patient
• Device Model Number: 661P
• Device Catalogue Number: 661P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HEATED HUMIDIFIER SN #(B)(6).; HUMIDIFIER S/N (B)(6).; HEATED HUMIDIFIER SN #: (B)(4)
• Patient Outcome(s): Hospitalization
• Patient Sex: Male