MAUDE Adverse Event Report: COOPERSURGICAL, INC. BT37 BENCHTOP INCUBATOR

Model Number BT37

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow up report will be filed.(b)(4).

Event Description

2pn arrest.Total cleavage arrest between day1 and day2.(b)(4).

Event Description

2pn arrest.Total cleavage arrest between day1 and day2.Ref e-complaint-(b)(4).

Manufacturer Narrative

Reference: e-complaint-(b)(4).Investigation: x-inspected returned samples.Analysis and finding: a review of the 2-year complaint history for the bt37 benchtop incubator shows no similar complaints on file.This is an isolated event.The bt37 benchtop incubator is a purchased product and is a dock to stock item.Upon investigation of the returned bt37 benchtop incubator, it revealed a dead battery, a nonfunctioning power supply, and a burnt mother board and it also needed lid gasket updates.The complaint condition was confirmed.Coopersurgical's service and repair department replaced battery, power supply and main circuit board, and performed routine maintenance by replacing lid gaskets, cam handle assembly, filter and latch assembly.The serviced bt37 benchtop incubator was calibrated and tested to quality specification and then returned to the customer.Reference repair order# (b)(4).Root cause cannot be reliably determined at this time and it is most likely attributed to improper handling.Coopersurgical will continue to monitor this complaint condition for any trends.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.Correction and/or corrective action: none.Reason: no changes to the process or procedure.Was the complaint confirmed? yes.Coopersurgical will continue to monitor this complaint condition in the coopersurgical cip (continuous improvement program) program for any trends, as a product malfunction only.Based on the analysis of the device, all current and available information received and investigation findings it has been determined that the described condition is not a reportable event.

• Brand Name: BT37 BENCHTOP INCUBATOR
• Type of Device: BT37 BENCHTOP INCUBATOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8808568
• MDR Text Key: 151852544
• Report Number: 1216677-2019-00209
• Device Sequence Number: 1
• Product Code: MQG
• Combination Product (y/n): N
• PMA/PMN Number: K121566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BT37
• Device Catalogue Number: BT37
• Device Lot Number: 24477
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other