MAUDE Adverse Event Report: KING SYSTEMS CORPORATION; TUBING, PRESSURE

Catalog Number 60742

Device Problems Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)

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

Event Date 06/19/2015

Event Type  malfunction  

Event Description

The sticker that was placed on the valve of the jackson-rees norman elbow thumb slide valve device was put on upside down.The sticker was to indicate if the valve was open or closed.Thus the valve was closed when in the "open" position and visa versa.
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manufacturer response for jackson-rees modification: norman elbow thumb slide valve 7ft oxygen tubing 2 liter bag, jackson-rees: norman elbow thumb slide valve (per site reporter).
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returning the device next week and will await a response.

• Type of Device: TUBING, PRESSURE
• Manufacturer (Section D): KING SYSTEMS CORPORATION; 15011 herriman boulevard; noblesville IN 46060
• MDR Report Key: 4938227
• MDR Text Key: 6253629
• Report Number: 4938227
• Device Sequence Number: 1
• Product Code: BYX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 60742
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2015
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 92