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

Model Number IPN915491

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the operators observed the laryngoscope handle overheated while waiting the birth of the newborn baby that needed to be intubated." allegded event occurred during equipment service.No patient involvement.Handle was not used.Device was replaced.

Event Description

It was reported that "the operators observed the laryngoscope handle overheated while waiting the birth of the newborn baby that needed to be intubated." no patient involvement.Handle was not used.Device was replaced.

Manufacturer Narrative

(b)(4).The customer returned one 145100 dolphin standard water resist hd handle for investigation.The handle was returned with a rusch equiplite metal disposable miller 0 attached to it.The visual examination did not reveal any obvious defects or anomalies, as the device appears typical.All edges/surfaces of the returned blade and handle were examined with no traces of battery fluid leakage, loose pin contacts shell/top piece/unintended metal which could lead to short circuit and high-temperature output from the device that would be able to overheat the handle as reported.The functional inspection was performed per laryngoscope ifu by pushing downward on the blade to release it from the handle.The blade and handle were reattached and disassembled multiple times with no issues observed of overheating.The complaint cannot be confirmed.To simulate the customer reported failure functional testing of the blade was performed with two fresh blades and noted that the handle was working perfectly when a handle was tested with these blades.There were several small scratch marks and a lot of dirt/residue noted on the internal locking mechanism of the handle.These marks reveal that the device has been used multiple times by the end user, and they are indicative that the device was working perfectly prior to this event and has been used many times.During functional testing of the complaint device, the customer reported defect of overheating of the handle was not possible to reproduce after testing with three different blades.There were no anomalies revealed during functional testing that would be able to contribute to handle overheating issue.The device history record for lot code 181201 was reviewed and no issue that could have contributed to the reported failure were noted.The device was manufactured according to release specification.The ifu for this product states, "attach blade to compatible handle.Click into place.To switch on, pull blade up.To switch off, fold blade down.Return to off position after use." the complaint cannot be confirmed.Visual inspection did not reveal any obvious defects or anomalies, as the device appears typical.Functional testing revealed that the blade and handle were reattached and disassembled multiple times, with no issues noted of handle overheating observed.There were no anomalies revealed during functional testing that would contribute to the handle overheating of a handle for an end user in any way.A device history record review was performed, with no issues found that could have contributed to the reported failure.No problem was found with the returned device.Teleflex will continue to monitor and trend complaints of this nature.

• Brand Name: RUSCH DOLPHIN W/P HANDLE: MINI
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15145297
• MDR Text Key: 302770921
• Report Number: 8030121-2022-00025
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704711717
• UDI-Public: 14026704711717
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN915491
• Device Catalogue Number: 145100
• Device Lot Number: 181201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BLADE; BLADE