MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PLATINUM 10 CONCEN W/SENS O2 9153642105; GENERATOR, OXYGEN, PORTABLE

Model Number IRC10LXO2

Device Problems No Audible Alarm (1019); No Device Output (1435); Failure to Deliver (2338)

Patient Problem Death (1802)

Event Date 12/13/2016

Event Type  Death  

Manufacturer Narrative

There is insufficient information at this time to determine if the irc10lxo2 concentrator caused or contributed to the passing of the end user.There was no autopsy done due to the end user being in the final stages of copd and his extensive list of medical conditions.End user had gone from (b)(6) pounds to (b)(6) at his last doctor visit.End user was on 4 lpm when resting and 6 lpm when active.Dealer does not know cause of death and death certificate was not provided to dealer.End users spouse just woke up and her husband had passed away in his sleep.She did not think oxygen was coming out of the unit but unit was not tested.Dealer obtained the unit and will be returning said unit to invacare for evaluation.No further information provided or expected until unit is evaluated by invacare engineering.Should additional information become available a supplemental record will be filed.

Event Description

Dealer reported that the irc10lxo2 stationary concentrator was in the on position and running but allegedly with no oxygen output.The end user was a 24 hour user and a copd patient, he expired in his sleep.The dealer stated that the wife alleged that she woke up and her husband was not alive.She stated to the dealer that the concentrator was in the "on" position and was running without an alarm.

Manufacturer Narrative

The irc0lxo2 concentrator was returned for evaluation, and subsequent testing did not verify the complaint.Per the evaluation: visual inspection indicated that the hour meter read 186.35 hours.The concentrators exterior found minor cosmetic flaws but no structural damage.Both the power cable & plug were inspected and found to be undamaged.Inspection of the inlet filter found two large dark spots on the filter trap.Functional testing: at power up, the concentrator appropriately gave a start-up alarm.The flow meter was set to 0 lpm and the concentrator gave a flow obstruction alarm.The flow meter was opened & closed several times and the alarm sounded each time the meter was closed, thus, the reported issue of the concentrator not alarming for flow obstruction could not be confirmed.Next, the power plug was pulled and the concentrator appropriately alarmed for sudden power loss.In summary, basic alarm functionality was confirmed.A basic performance test at full scale of the flow meter was conducted.The concentrator was allowed to run for 30 minutes continuously.No alarms were observed during this period.After 30 minutes output pressure and o2 purity were measured at 9.4 psi and 95.5% for a flow rate of 9.9 lmp.Based on the maximum output pressure and acceptable o2 purity listed in the service manual the concentrator functioned properly at full scale of the flow meter.The 6 lpm setting was tested and output pressure and o2 purity were measured at 9.5 psi and 95.5% respectively.The 4 lpm setting was also tested with output pressure and o2 purity measuring at 9.5 psi and 95.6% respectively.The concentrator functioned properly, therefore, the reported issue of the concentrator giving no output when powered on could not be confirmed.Conclusion: in its "as received" condition, the complaint was not confirmed.The irc10lxo2's flow obstruction alarm was observed to operate properly.Likewise, output pressure and o2 purity at 4 lpm, 6 lpm and full scale of the flow meter were found to satisfy typical normal operating parameters, thus indicating proper oxygen output.Thus, no malfunction could be confirmed.

Event Description

Dealer reported that the irc10lxo2 stationary concentrator was in the on position and running but allegedly with no oxygen output.The end user was a 24 hour user and a copd patient, he expired in his sleep.The dealer stated that the wife alleged that she woke up and her husband was not alive.She stated to the dealer that the concentrator was in the "on" position and was running without an alarm.

• Brand Name: PLATINUM 10 CONCEN W/SENS O2 9153642105
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 6192923
• MDR Text Key: 62937810
• Report Number: 1031452-2016-03654
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IRC10LXO2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2017
• 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): Death
• Patient Weight: 50