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

Model Number IPN048614

Device Problem Battery Problem: Low Impedance (2973)

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

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "power on both batteries were too low, does not light up sufficiently.There may be a loose contact".No patient involvement reported.

Event Description

It was reported that "power on both batteries were too low, does not light up sufficiently.There may be a loose contact".No patient involvement reported.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: RUSCH MRI HANDLE BATTERIES PACK OF 1
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 12168721
• MDR Text Key: 261589876
• Report Number: 8030121-2021-00024
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704616272
• UDI-Public: 14026704616272
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN048614
• Device Catalogue Number: 005853300
• Device Lot Number: 200201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1