MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS HOMEFILL CYLINDER ASM POST VALVE, M9 SIZE 9153647490; GENERATOR, OXYGEN, PORTABLE

Model Number HF2POST9

Device Problems Break (1069); Detachment Of Device Component (1104); Dent in Material (2526)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Unit is awaiting a full evaluation by engineering.Should additional information become available a supplemental record will be filed.

Event Description

Dealer states the brass fitting on a homefill tank broke off while it was filling on the homefill unit.The dealer said it dented the compressor and shot 20-30 feet across the room.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: stationary concentrators, respiratory cylinder/regulator, homefill.Hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: visual inspection- the cylinder was received with two broken pieces present.The toggle valve was received broken off from the main body of the cylinder.The cylinder fill port was also broken off from the main body of the cylinder.The cylinder did not exhibit any dents or bends, but a scuff was present on the body.The homefill compressor was received in relatively good condition.No scratches or damage seemed to be present other than a small dent in the control panel.The oxygen concentrator was received in good condition without any scratches, dents, or other damage.Functional observations- the concentrator was functioning correctly and within specifications.The homefill was able to properly fill a test cylinder and shut off when the cylinder was full.The retuned cylinder was unable to be tested due to the broken fill port.Conclusions - utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the fill port breaking off of the homefill ml9 post valve cylinder.The fill port was received broken off of the cylinder.The complaint that the fill port broke off while the cylinder and home fill were in use was unable to be confirmed.During functional testing with a test cylinder, the broken fill port was not replicated.The root cause of the broken fill port was unable to be determined.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: stationary concentrators, respiratory cylinder/regulator, homefill.Hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: visual inspection- the cylinder was received with two broken pieces present.The toggle valve was received broken off from the main body of the cylinder.The cylinder fill port was also broken off from the main body of the cylinder.The cylinder did not exhibit any dents or bends, but a scuff was present on the body.The homefill compressor was received in relatively good condition.No scratches or damage seemed to be present other than a small dent in the control panel.The oxygen concentrator was received in good condition without any scratches, dents, or other damage.Functional observations- the concentrator was functioning correctly and within specifications.The homefill was able to properly fill a test cylinder and shut off when the cylinder was full.The retuned cylinder was unable to be tested due to the broken fill port.Conclusions - utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the fill port breaking off of the homefill ml9 post valve cylinder.The fill port was received broken off of the cylinder.The complaint that the fill port broke off while the cylinder and home fill were in use was unable to be confirmed.During functional testing with a test cylinder, the broken fill port was not replicated.The root cause of the broken fill port was unable to be determined.Dealer states the brass fitting on a homefill tank broke off while it was filling on the homefill unit.The dealer said it dented the compressor and shot 20-30 feet across the room.

• Brand Name: HOMEFILL CYLINDER ASM POST VALVE, M9 SIZE 9153647490
• 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: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5406292
• MDR Text Key: 37353040
• Report Number: 1031452-2016-00407
• 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: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HF2POST9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• 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