MAUDE Adverse Event Report: COOPERSURGICAL, INC. G85 MINI INCUBATOR WITH

Model Number K22074

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2023

Event Type  malfunction  

Event Description

In an attempt to get the gas flow running, purge was pressed, and the bottle lid blew off.The regulator was at over 1 bar, whereas the manual states it should be less than 0.5 bar.Then, while removing the inlet tube, the welded bottle join broke off.1216677-2023-00086 g85 mini incubator k22074 (b)(4).

Manufacturer Narrative

Coopersurgical is currently investigating the reported condition.

Manufacturer Narrative

Distribution history.The complaint product was purchased by csi (venlo) from origio - olstykke.Manufacturing record review.Manufacturing record review not applicable to this product.Incoming inspection review.Incoming inspection record review not applicable to this product.Service history record.Service history not applicable for this product.Historical complaint review.A review of the 2-year complaint history showed no similar reported complaint conditions.Product receipt.The complaint product has not been returned to coopersurgical as this is a field service complaint.Visual evaluation.This is a field service complaint, there was no product returned for evaluation.If further information becomes available at a later date this investigation will be amended accordingly.Functional evaluation.This is a field service complaint, there was no product returned for evaluation.If further information becomes available at a later date this investigation will be amended accordingly.Root cause.This is a field service complaint, (b)(4).There was no product returned for evaluation.If further information becomes available at a later date this investigation will be amended accordingly.While no definitive root cause could be reliably determined, this issue may have been due to installation and end user error.This is an isolated incident.While investigating this complaint it was determined that the reported condition was not related to embryo damage.The potential risk was to the end user.Reportability reassessment with updated information was determined on 5/18/2023.

Event Description

No additional information.

• Brand Name: G85 MINI INCUBATOR WITH
• Type of Device: G85 MINI INCUBATOR WITH
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull VA 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, VA 06611 ; 4752651665
• MDR Report Key: 16991858
• MDR Text Key: 315838878
• Report Number: 1216677-2023-00086
• Device Sequence Number: 1
• Product Code: PUB
• UDI-Device Identifier: 00888937025057
• UDI-Public: 888937025057
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K22074
• Device Catalogue Number: K22074
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other