MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE E-CAIO; ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported an e-caio module sparked when attached to the main central processing unit.Noted during a check out of the product.

Manufacturer Narrative

(b)(4).A follow-up report will be submitted when the investigation is complete.

Manufacturer Narrative

The customer sent the module to depot repair and the central processing unit (cpu) board of the module was found to be the cause.Module was repaired in depot so further investigation cannot be done.The root cause for the cpu board remain unclear.The reported issue is possible when gas module cpu board is misaligned and d-connector metal housing makes contact to monitor connector pins.

• Brand Name: DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE E-CAIO
• Type of Device: ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; helsinki, ; FI
• Manufacturer (Section G): GE HEALTHCARE FINLAND OY; helsinki, ; FI
• Manufacturer Contact: deb lahr ; 540 w. northwest hwy; barrington, IL 60010 ; 8472774472
• MDR Report Key: 4199878
• MDR Text Key: 4962606
• Report Number: 9610105-2014-00016
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2014

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
• Other Device ID Number: 6538926
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 10/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1