MAUDE Adverse Event Report: ORIDION MEDICAL ORIDION MEDICAL; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number CS08657-02

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the unit did not generate an audible alarm.It was reported that there was no patient involvement.

Manufacturer Narrative

One sample was received for analysis and the reported issue was confirmed.Customer speaker was removed and reconnected.Audio was found to be intermittent based on the position of the white speaker wire connection at the speaker side.Visual inspection under magnification found a cracked solder joint.Speaker was removed and retained.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the unit did not generate an audible alarm.It was reported that there was no patient involvement.

• Brand Name: ORIDION MEDICAL
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• Manufacturer (Section G): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 6997677
• MDR Text Key: 91956484
• Report Number: 8044004-2017-05009
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10884521551503
• UDI-Public: 10884521551503
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS08657-02
• Device Catalogue Number: CS08657-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2017
• 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: Unknown
• Patient Sequence Number: 1