MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH MRI HANDLE BATTERIES PACK OF 1; LARYNGOSCOPE, RIGID

Model Number	IPN048614
Medical Device Problem Code	Battery Problem: Low Impedance (2973)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "power on both batteries was too low, does not light up sufficiently.There may be a loose contact".No patient involvement reported.
Event or Problem Description
It was reported that "power on both batteries was too low, does not light up sufficiently.There may be a loose contact".No patient involvement reported.
Additional Manufacturer Narrative
Qn# (b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturer reports: "upon investigation of the battery, we have performed the functional testing and noticed that after inserting the battery into the lab inventory mri laryngoscope handle and blade, the led of blade energized, and light was glowing constantly.Further to investigate the complaint sample of battery we have measured the voltage of battery and observed 3.2 volt against the specification of nominal voltage of 3v, and battery found acceptable against the nominal voltage specification of 3volt.Since the complaint sample of battery was found acceptable during functional testing and moreover, the measured voltage of the battery is 3.2 v against the 3.0 v of nominal voltage as per design specification.Even lux level obtained from the complaint sample was also measured more than 560 lux, so this complaint is found unjustified because complaint sample of battery does meet all the design and manufacturing release specification." the device history record of lot 200201 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.

• Brand Name: RUSCH MRI HANDLE BATTERIES PACK OF 1
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 12168885
• Report Number: 8030121-2021-00023
• Device Sequence Number: 4199295
• Product Code: CCW
• UDI-Device Identifier: 14026704616272
• UDI-Public: 14026704616272
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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
• Operator of Device: No Information
• Device Model Number: IPN048614
• Device Catalogue Number: 005853300
• Device Lot Number: 200201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1