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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL MEDISORB MULTI-ABSORBER ORIGINAL, DISPOSABLE; ABSORBENT, CARBON-DIOXIDE

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VYAIRE MEDICAL MEDISORB MULTI-ABSORBER ORIGINAL, DISPOSABLE; ABSORBENT, CARBON-DIOXIDE Back to Search Results
Model Number MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
Device Problem Crack (1135)
Patient Problem Low Oxygen Saturation (2477)
Event Date 08/24/2020
Event Type  Injury  
Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
Event Description
The customer reported major leak in the anaesthetic machine during an emergency.Leak was from a very visible crack in the canister and caused the patient's saturation to drop rapidly.The anaesthetist had to blow into the endotracheal tube to ventilate patient.However, the hospital confirmed that they have not checked the machine before use and conceded that the canister may have not been handled correctly by the staff.
 
Manufacturer Narrative
Device evaluation.No product sample has been returned for evaluation.However, review of the device history record reveals no defects in any of the canisters.Also, canisters are packaged in a carton that meets vyaire drop testing specification as well as labeled fragile and to handle with care.They are also 100% leak tested on the production line and failures are automatically rejected.Photographic evidence supplied in this case clearly shows that the canisters have extensive cracks and have been subjected to a significant impact, indicative of being dropped once out of the carton.The end user report stated that "we concede that canisters may not be handled correctly by staff." as such, root cause of failure has been determined to be damage from device misuse.
 
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Brand Name
MEDISORB MULTI-ABSORBER ORIGINAL, DISPOSABLE
Type of Device
ABSORBENT, CARBON-DIOXIDE
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
MDR Report Key10616982
MDR Text Key209592749
Report Number3002807637-2020-00007
Device Sequence Number1
Product Code CBL
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 09/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
Device Catalogue Number8003138
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/07/2020
Initial Date FDA Received10/01/2020
Supplement Dates Manufacturer Received03/10/2021
Supplement Dates FDA Received03/31/2021
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight170
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