MAUDE Adverse Event Report: PRECISION MEDICAL HIGH HUMIDITY AEROSOL COMPRESSOR; OXYGEN CONCENTRATOR

Model Number PM15F

Device Problems Failure to Deliver (2338); Delivery System Failure (2905)

Patient Problems Hypoventilation (1916); Hypoxia (1918); Respiratory Distress (2045)

Event Date 01/30/2014

Event Type  Injury  

Event Description

Pt's o2 concentrator stopped working.The pt was to receive o2 through his trach.When rn arrived, pt's o2 sats were down to 82%.The concentrator was hot to touch.The 911 was called.Emts started o2 on pt and his o2 sats returned to 98%.Another concentrator was not available.A 911 transported the pt to the er.He was kept overnight and sent home on (b)(6) 2014 as another concentrator had been delivered.Broken concentrator was returned to (b)(4).(b)(4) staff shared their biomedical department had the device.

• Brand Name: HIGH HUMIDITY AEROSOL COMPRESSOR
• Type of Device: OXYGEN CONCENTRATOR
• Manufacturer (Section D): PRECISION MEDICAL; north hampton PA 18067
• MDR Report Key: 4474864
• MDR Text Key: 5400351
• Report Number: 4474864
• Device Sequence Number: 1
• Product Code: CAW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PM15F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2014
• Device Age: 16 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 17 YR
• Patient Weight: 61