MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH MRI COND FIBER OPTIC BATTERY; LARYNGOSCOPE, RIGID

Model Number IPN048614

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges the battery died after one month of use.Another battery was used with success with the same charger.No patient harm or consequence reported.

Event Description

Customer complaint alleges the battery died after one month of use.Another battery was used with success with the same charger.No patient harm or consequence reported.

Manufacturer Narrative

(b)(4).The device was returned and sent to the manufacturing site for evaluation.The manufacturing site reports "the device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Product received at site and confirmed the reported failure of power failure issue.Mri cond fiber optic battery manufactured in aug 2019 and mri cartridges is having warranty or shelf life of 18 months and cumulative life span of battery approx.30 min max.We found that the mri cartridge was not working.We inserted new batteries in cartridge and found that it was working perfectly, so we are assured that electrical circuit of cartridge is perfect.We tried to get information from customer about approximate usage of battery before going to dead but unfortunately no specific answer received.Based on internal investigation, we can conclude that product has used for more than specified useful life.".

• Brand Name: RUSCH MRI COND FIBER OPTIC BATTERY
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9571338
• MDR Text Key: 189441062
• Report Number: 8030121-2020-00019
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

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
• Device Operator: No Information
• Device Expiration Date: 02/13/2021
• Device Model Number: IPN048614
• Device Catalogue Number: 005853300
• Device Lot Number: 190801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.