MAUDE Adverse Event Report: CAIRE INC. HELIOS H850; UNIT, LIQUID OXYGEN, PORTABLE

Model Number H850EU

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Emphysema (1832); Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

Unit is being returned for evaluation.If any new information is discovered, a followup report will be submitted.

Event Description

On the (b)(6) 2017 (b)(6) patient's husband called (b)(6) customer service centre to let us know that his wife had collapsed, because the h850 had not worked.A call on 1st september 2017 with the patient's husband informed of the following.The husband filled the h850 on (b)(6) as usual and drove his wife to an appointment to (b)(6) (lung specialist) at 10 a.M.First the wife called asking for collection, then the doctor's surgery, saying that the wife had been taken to hospital in (b)(6), because she had collapsed.In the hospital in (b)(6) the husband was told that the cause had been "not enough oxygen", and he didn't know anything else.The wife recovered soon and was discharged on (b)(6).We were granted permission to contact the doctor's surgery to know the diagnosis and the events.The call took place on 4th september and we were told the following: patient (b)(6) had already finished her visit, left the surgery, and suddenly collapsed 50 m away.The doctor was called, she was responding and was not unconscious, but did not know what had happened.The previous routine check had revealed a high pco2 (po2=66%), that the doctor had thought was caused by a low use of the cpap respiration by the patient.He did not carry out the blood gas analysis because there was no evidence for the need to.Colleagues from the leoben hospital of the pulmology ward let him know that a faulty mobile unit (h850) was considered the cause and triggered hypoxia.The course of events as well as the condition copd iv were confirmed by the doctor.

Event Description

The unit was evaluated.The portable units demand settings are not functional as only a continuous flow rate is being delivered when on demand flow settings.Checking the flow rate settings is part of manufacturers recommended maintenance and unit needs repair due to faulty pdd assembly.Despite this the alleged incident reported could not be duplicated as the portable is delivering o2.

• Brand Name: HELIOS H850
• Type of Device: UNIT, LIQUID OXYGEN, PORTABLE
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer (Section G): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer Contact: neal maloy ; 2200 airport industrial drive; suite 500; ball ground, GA 30107 ; 7707217700
• MDR Report Key: 6897529
• MDR Text Key: 89417716
• Report Number: 3004972304-2017-00031
• Device Sequence Number: 1
• Product Code: BYJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K993220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: H850EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR