MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION HUM CARE PACK DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSXHCP

Device Problems Break (1069); Thermal Decomposition of Device (1071); Smoking (1585)

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

Event Date 02/04/2023

Event Type  Injury  

Event Description

This is a nursing home resident who was using a rental philips respironics remediated auto bipap with bleed in oxygen, and the nursing home staff called and reported the unit was smoking.Staff reported no damage or injury to user or facility.They stopped using device, isolated it and sent it back to icp.Icp send new auto bipap for resident to use.Damaged unit was evaluated and there was no evidence of user/staff mishandling and the electrical inlet at the machine had scorching around the inlet and the electrical plug in at the machine was badly damaged and smelled of smoke.Our technicians were unable to assess the unit further as the damage did not allow for powering up of the device.The unit involved was rep dreamstationautobipap dom fef#: dsx700s11f, sn: (b)(4) attached heated humidifier identifier: dreamstation hum care pack dom ref#: dsxhcp, sn: (b)(4), ac power supply: sn: (b)(4).This remediated unit was received from respironics and put in service at icp on: 10/17/2022; placed on this resident on: (b)(6) 2022.

• Brand Name: DREAMSTATION HUM CARE PACK DOM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 16353298
• MDR Text Key: 309403653
• Report Number: MW5114853
• Device Sequence Number: 2
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/07/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DSXHCP
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White