MAUDE Adverse Event Report: SALTER LABS OXYGEN MASK (ADULT), HIGH CONCENTRATION NON-REBREATHER; MASK, OXYGEN, NON-REBREATHING

Model Number 8140TG-7

Device Problem Device Slipped (1584)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/30/2022

Event Type  malfunction  

Event Description

Recently having multiple incidents with nrb (non-rebreather) masks having the bag pop out from under the green tape holding it in place.The bag is typically intact/not torn when it pops off the mask.It appears that the green securement tape is failing.Patients are typically on vapotherm when this happens, not sure if this is affecting the integrity of the securement tape.The mask information has been discarded in the majority of the reported events, but 3 lot numbers were identified (2 on same patient).Lot (10)201019, lot (10)210927 on this patient.Lot (10)211206 on another patient.Patients involved in the incidents have desaturated from the events, but recovered when new nrb applied.Not aware of any major adverse outcomes from events.8 total events reported involving 5 different patients.

• Brand Name: OXYGEN MASK (ADULT), HIGH CONCENTRATION NON-REBREATHER
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• MDR Report Key: 13534143
• MDR Text Key: 285612848
• Report Number: 13534143
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8140TG-7
• Device Catalogue Number: 8140TG-7
• Device Lot Number: 201019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Race: White