MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH MRI SET: HDL+ MIL 1,2,3 MAC 2,3,4; LARYNGOSCOPE, RIGID

Model Number IPN048624

Device Problem Battery Problem (2885)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the batteries in the mri laryngoscope kit work but become dull immediately".No patient involvement reported.

Event Description

It was reported "the batteries in the mri laryngoscope kit work but become dull immediately".No patient involvement reported.

Manufacturer Narrative

(b)(4), the customer returned one rusch mri handle battery pack (005853300) from a rusch mri set (005852300) for investigation.Visual examination did not reveal any obvious defects or anomalies.Functional inspection was performed per mri laryngoscope ifu by inserting the battery into a known good lab inventory mri laryngoscope handle and attaching a known good lab inventory blade onto the handle.The led lit up and stayed lit for 5 minutes.The light did not turn off or get dim.The battery voltage was measured to be 3.161 v dc which is consistent with the nominal voltage.The device history record of lot 200801 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Functional testing has confirmed no fault found with this battery pack.The battery was able to be inserted into a lab inventory handle with no issues and illuminate a lab inventory blade for 5 minutes with no sign of dimming.Based on the device returned, no problem was found on this sample.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: RUSCH MRI SET: HDL+ MIL 1,2,3 MAC 2,3,4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11400237
• MDR Text Key: 234305178
• Report Number: 8030121-2021-00007
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704616371
• UDI-Public: 14026704616371
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN048624
• Device Catalogue Number: 005853300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MRI LARYNGOSCOPE KIT WITH BLADE AND HANDLE; MRI LARYNGOSCOPE KIT WITH BLADE AND HANDLE; MRI LARYNGOSCOPE KIT WITH BLADE AND HANDLE