MAUDE Adverse Event Report: SALTER LABS SALTER LABS OXYGEN DELIVERY TUBING; OXYGEN SUPPLY TUBING

Model Number 2025G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoxia (1918)

Event Date 12/25/2015

Event Type  Injury  

Manufacturer Narrative

This is a resubmission at the request of fda.There are no changes to the base data or information from the original submission no further investigation could be conducted because product was not returned and no lot number was provided to review manufacturing records.Other similar complaints/product was investigated and measured for wall thickness and kinking.In most cases it was found that the tubing was within specification; however was found to be at the low specification.Those samples were flow tested and were able to deliver air flow while in a "kinked" state.It is likely that theses samples would have had similar properties if they had been returned.Ra: kinking is identified in the risk analysis.

Event Description

Patient reports hypoxia due to kinked o2 supply tubing.

• Brand Name: SALTER LABS OXYGEN DELIVERY TUBING
• Type of Device: OXYGEN SUPPLY TUBING
• Manufacturer (Section D): SALTER LABS; 2710 northridge dr., nw, ste a; grand rapids, mi
• Manufacturer (Section G): SALTER LABS; 2710 northridge dr., nw, ste a; grand rapids, mi
• Manufacturer Contact: mara caler ; 2710 northridge dr., nw, ste a; grand rapids, mi ; 7957094
• MDR Report Key: 5705135
• MDR Text Key: 203105541
• Report Number: 3000219639-2016-00005
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2025G
• Device Catalogue Number: 2025G-25
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other