MAUDE Adverse Event Report: RUSCH DOLPHIN W/P HANDLE: MINI; LARYNGOSCOPE, RIGID

Model Number IPN048428

Device Problem Temperature Problem (3022)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/07/2021

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that: "involved a premature newborn born baby (born on (b)(6)) positioned on a babytherm 8010 table (supplier (b)(4)).On (b)(6) 2021, the baby had a deterioration of his clinical condition (bradycardias and desaturations).This clinical condition required his intubation.The intern doctor had difficulties to perform the intubation.The laryngoscope blade was left whilst still being snapped on the handle, during few minutes (2 to 3 minutes), on the table in contact of the child.When the pediatrician arrived to perform the intubation, the laryngoscope handle was hot.This handle was in contact with the outer left forearm of the child.The child was sedated therefore he was not sensitive to pain.It resulted in a significant burn in the 2nd or even 3rd degree on the outside of the left forearm of the child.On (b)(6) 2021, the medical team had decided that if the scab comes off, they would monitor the healing.Otherwise, or if the burn becomes inflammatory, then decision to perform a skin graft.A close follow-up by plastic surgeons is carried out".Patient condition reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The sample was returned and sent to the manufacturing site for evaluation.The manufacturer reports a visual exam was performed and no battery fluid leakage was observed, which could contribute to the burn issue reported in the complaint.No short circuit or lose pin handle was found.In addition, the handle was tested for 30 minutes by keeping the handle and blade in the exposed position with new batteries and the temperature was recorded.The temperature was found to be normal.All parts of the handle were inspected and found to be within specification.A device history record review was performed on the lot number reported and no relevant findings were identified.The ifu for this product states: "bulbs on conventional laryngoscope blades, if left illuminated in an exposed position, may generate heat sufficient to burn human tissue." it was reported by the customer "the laryngoscope blade was left whilst still being snapped on the handle, during few minutes (2 to 3 minutes), on the table in contact of the child."; therefore the root cause assigned to this complaint is user error as the customer has not followed the product ifu and kept the handle in an exposed position on the babytherm 8010 which was already preheated.No issues were found with the returned device.As a follow up, an in-service has been requested for this customer.

Event Description

It was reported that: "involved a premature newborn born baby (born on (b)(6) 2021) positioned on a babytherm 8010 table (supplier drager).On (b)(6) 2021, the baby had a deterioration of his clinical condition (bradycardias and desaturations).This clinical condition required his intubation.The intern doctor had difficulties to perform the intubation.The laryngoscope blade was left whilst still being snapped on the handle, during few minutes (2 to 3 minutes), on the table in contact of the child.When the pediatrician arrived to perform the intubation, the laryngoscope handle was hot.This handle was in contact with the outer left forearm of the child.The child was sedated therefore he was not sensitive to pain.It resulted in a significant burn in the 2nd or even 3rd degree on the outside of the left forearm of the child.On (b)(6) 2021, the medical team had decided that if the scab comes off, they would monitor the healing.Otherwise, or if the burn becomes inflammatory, then decision to perform a skin graft.A close follow-up by plastic surgeons is carried out".Patient condition reported as "fine".

• Brand Name: RUSCH DOLPHIN W/P HANDLE: MINI
• Type of Device: LARYNGOSCOPE, RIGID
• MDR Report Key: 12452362
• MDR Text Key: 270804605
• Report Number: 8030121-2021-00028
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704711717
• UDI-Public: 14026704711717
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN048428
• Device Catalogue Number: 145100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: LARYNGOSCOPE BLADE; LARYNGOSCOPE BLADE; LARYNGOSCOPE BLADE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 6 DA