MAUDE Adverse Event Report: NULL WARMER BLOOD ELECTROMAGNET; WARMER, BLOOD, ELECTROMAGNETIC RADIATION

Catalog Number H-1100-FR-230V

Device Problem Low Audible Alarm (1016)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2022

Event Type  malfunction  

Event Description

It was reported that after preventive maintenance, the device had a water flow defect that was too low.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-03713.The report was submitted in error.

• Brand Name: WARMER BLOOD ELECTROMAGNET
• Type of Device: WARMER, BLOOD, ELECTROMAGNETIC RADIATION
• Manufacturer (Section G): NULL
• MDR Report Key: 13565920
• MDR Text Key: 288657021
• Report Number: 3012307300-2022-03713
• Device Sequence Number: 1
• Product Code: BSA
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H-1100-FR-230V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1