MAUDE Adverse Event Report: WESTERN/SCOTT FETZER CO. GRAB 'N GO III PORTABLE MEDICAL OXYGEN SYSTEM; REGULATOR, PRESSURE, GAS CYLINDER

Model Number PRX-9369

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

Information provided by the initial reporter indicated the subject unit was being retained by the hospital's risk management team for evaluation.The subject unit was eventually released to the initial reporter and their preliminary evaluation indicates the subject device was impacted on the handwheel/knob in some manner that damaged the shaft and flow control mechanism.The vipr system was vented and the pressure gauge functioned normally.The actual source of the impact damage is unknown.The unit is approximately 15.5 years old.Western has requested return of the subject unit to western for evaluation.Not returned to manufacturer.

Event Description

As reported to western, the customer stated the gauge read full but no product was released from the cylinder.The unit is a valve integrated pressure regulator (vipr) system.The unit was put into use on a patient and it was noticed that it was not dispensing oxygen.They checked the flow and discovered there was no flow.A different unit was obtained and used to administer oxygen.There was no adverse outcome to the patient.

Manufacturer Narrative

Initial visual inspection of the subject device found damage (i.E., bent flow control shaft) from impact of some nature.The unit is approximately 15.5 years old.Flow testing found no measurable flow from the outlet at any flow setting.Disassembly and inspection found a significant amount of moisture present throughout the low pressure cavities of the regulator.The cause of the failure was moisture introduced into the system after release from western.The actual source or cause of the moisture is unknown, but was most likely moisture being introduced into the cylinder system from water remaining in the cylinder after hydrostatic testing.The moisture entered the regulator control assembly and caused the nylon orifice plate to swell to the point of seizure in the flow control bonnet.In such a condition, rotation of the flow control knob resulted in the orifice plate becoming stripped from the flow control shaft so that the shaft rotated independently from the orifice plate, which resulted in the loss of flow control.

• Brand Name: GRAB 'N GO III PORTABLE MEDICAL OXYGEN SYSTEM
• Type of Device: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): WESTERN/SCOTT FETZER CO.; 875 bassett rd; westlake OH 44145
• Manufacturer Contact: julii lindquist ; 875 bassett rd; westlake, OH 44145 ; 4408712160
• MDR Report Key: 5919548
• MDR Text Key: 53668201
• Report Number: 1526809-2016-00004
• Device Sequence Number: 1
• Product Code: CAN
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRX-9369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2001
• 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