MAUDE Adverse Event Report: COOPERSURGICAL, INC. PUMP,OBSTETRICS,RPRL,GAS

Model Number	10022
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported conditoin.
Event or Problem Description
(b)(4).
Additional Manufacturer Narrative
Investigation initiated manufacturer's investigation no sample returned distribution history: distribution history cannot be determined as the customer has not provided the requested information.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed, and this complaint amended accordingly.Incoming inspection review: not applicable.Service history record: no additional service history records can be determined as the customer had not provided information allowing for a search.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint condition.Product receipt: the complaint unit was not returned.Visual evaluation: visual examination of the complaint was not possible as the complaint unit was not returned.Functional evaluation: functional evaluation was not possible as the complaint unit was not returned.Root cause: a root cause can not be determined with the information provided by the customer.Corrective actions no corrective actions possible as the unit was not returned.Coopersurgical will continue to monitor this complaint condition for trends.This complaint will be updated if useful and pertinent information is provided from the multiple requests made.No further corrective action is necessary.Was the complaint confirmed? no.
Event or Problem Description
Customer stated: "mityvac stays inflated to 15 mm hg, potentially could cause harm to infant.Our technician realized the equipment was defective".10022 pump obstetrics rprl gas e-complaint (b)(4).

• Brand Name: PUMP,OBSTETRICS,RPRL,GAS
• Common Device Name: PUMP,OBSTETRICS,RPRL,GAS
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10949909
• Report Number: 1216677-2020-00287
• Device Sequence Number: 872020
• Product Code: HDB
• UDI-Device Identifier: 00888937003147
• UDI-Public: 888937003147
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K980212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: 10022
• Device Catalogue Number: 10022
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown