MAUDE Adverse Event Report: SALTER LABS OXYGEN TUBING (GREEN) WITH 2 STANDARD CONNECTORS; OXYGEN SUPPLY TUBING - 25 FEET

Model Number 2025G-25

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Bone Fracture(s) (1870); Pleural Effusion (2010)

Event Date 11/09/2016

Event Type  Death  

Event Description

Patient was found per her daughter sitting on the floor between the shower and her wheelchair.Patient did not call daughter for assistance.Patient noted with a large frontal scalp hematoma.Patient stated she tripped over oxygen tubing and landed on her head.Daughter had placed a bag of ice on patient's head.Patient was transported to a local hospital due to complaints of neck pain and then transported via helicopter to a trauma hospital due to ct scan revealing a c1, c2 fracture.Surgeon recommended placement of rod to stabilize fracture however the family opted for non-operative treatment.Aspen brace applied.During hospital stay her pleural effusion increased and daughter expressed inpatient comfort care only for patient.The patient subsequently expired on (b)(6) 2016.

• Brand Name: OXYGEN TUBING (GREEN) WITH 2 STANDARD CONNECTORS
• Type of Device: OXYGEN SUPPLY TUBING - 25 FEET
• Manufacturer (Section D): SALTER LABS; 100 west sycamore rd.; arvin CA 93203
• MDR Report Key: 6129318
• MDR Text Key: 61016280
• Report Number: 6129318
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2025G-25
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2016
• Distributor Facility Aware Date: 11/09/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OVERBED TABLE; OXYGEN CONCENTRATOR; OXYGEN PORTABLE SYSTEM (E-CYLINDER); STANDARD 18" WHEELCHAIR
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Age: 86 YR
• Patient Weight: 63