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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Respiratory Failure (2484)

Event Date 02/27/2023

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

The manufacturer received a voluntary medwatch (mw5115793) from an end user¿s caretaker (mother) alleging her son¿s first bipap machine broke in 2022 and he was, therefore, without a replacement device for two months.The replacement machine was received around january 15, 2023.The caretaker alleges that after using the replacement bipap device, her son became very sick and was admitted to the hospital (intensive care unit) for pulmonary failure and a systemic infection (teeth, skin, stomach, and blood).The caretaker alleges her son was treated with antibiotics and steroids and was released after one week in the hospital.The caretaker alleges that when the dme tried to download her son¿s sleep data (from the card), it still had the name of the previous user which prevented her son¿s information from being recorded.The caretaker believes her son became sick due to the reconditioned machine not being properly cleaned/disinfected from the previous owner.The caretaker reported her son is using a bipap machine from another company and is doing better.The device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

The manufacturer previously reported after receiving a voluntary medwatch (mw5115793) from an end user¿s caretaker (mother) alleging her son¿s first bipap machine broke in 2022 and he was, therefore, without a replacement device for two months.The replacement machine was received around january 15, 2023.The caretaker alleges that after using the replacement bipap device, her son became very sick and was admitted to the hospital (intensive care unit) for pulmonary failure and a systemic infection (teeth, skin, stomach, and blood).The caretaker alleges her son was treated with antibiotics and steroids and was released after one week in the hospital.The caretaker alleges that when the dme tried to download her son¿s sleep data (from the card), it still had the name of the previous user which prevented her son¿s information from being recorded.The caretaker believes her son became sick due to the reconditioned machine not being properly cleaned/disinfected from the previous owner.The caretaker reported her son is using a bipap machine from another company and is doing better.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16761130
• MDR Text Key: 313496183
• Report Number: 2518422-2023-09067
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• 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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization