MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; BSZ

Model Number C30

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2014

Event Type  malfunction  

Event Description

It was reported that during system check out, the internal tests failed since the target pressure could not be reached.There was no patient connected to the anesthesia workstation at the time of the event.(b)(4).

Manufacturer Narrative

A supplemental medwatch report will be provided when the investigation is finished.

Manufacturer Narrative

The anesthesia workstation was investigated at the hospital by our company representative.The unit was found with a leaking nozzle unit in the oxygen fresh gas module.While at the hospital, the company representative also performed the annual preventive maintenance on the anesthesia workstation, which includes the replacement of nozzle units in all 4 gas modules (including the oxygen fresh gas module).Function tests were performed and the unit was returned to service.The received test logs cannot confirm any effects from the leaking nozzle unit since the performed.System check outs were cancelled at an early state.The leaking nozzle unit has not been available for investigation and we are therefore unable to determine the root cause of the leaking nozzle unit.

• Brand Name: FLOW-I C30
• Type of Device: BSZ
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer Contact: magnus lindqvist ; rontgenvagen 2; solna S-171-54 ; SW S-17154 ; 7307705
• MDR Report Key: 4375941
• MDR Text Key: 5285840
• Report Number: 8010042-2014-00589
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 12/12/2014

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: Health Professional
• Device Model Number: C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1