MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. PERFECTO2 OXYGEN CONCENTRATOR 9153646962; GENERATOR, OXYGEN, PORTABLE

Model Number IRC5P

Device Problem Device Alarm System (1012)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

This product was evaluated and repaired by an independent repair center.  should additional information become available, a supplemental record will be filed.

Event Description

Per the independent repair center, the customer alleged problem is the alarm will not function.The key failure is on/off switch has no alarm.

• Brand Name: PERFECTO2 OXYGEN CONCENTRATOR 9153646962
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 21512 1; CH 215121
• Manufacturer (Section G): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 21512 1; CH 215121
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5956924
• MDR Text Key: 55261302
• Report Number: 3008262382-2016-00648
• 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: other
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC5P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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