MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 650; ANESTHESIA GAS MACHINE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Unique identifier: (b)(4).A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The carrier com express board was replaced to resolve the reported issue.

Event Description

The hospital reported the unit had an error that results in a loss of ventilation.There was no report of patient involvement.

• Brand Name: CARESTATION 650
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• MDR Report Key: 12377165
• MDR Text Key: 280705807
• Report Number: 9710602-2021-00264
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K151570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1