MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number JADA-1001

Device Problem Suction Failure (4039)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

In this use of jada, care was escalated for the original diagnosis of postpartum hemorrhage, consistent with the device labeling.The device labeling statement related to reassessment and escalation is as follows: "warning: signs of patient deterioration or failure to improve indicate the need for reassessment and possibly more aggressive treatment and management of postpartum hemorrhage (pph)/abnormal postpartum uterine bleeding." it is unclear whether the jada malfunctioned based on the information that is available at this time, but out of an abundance of caution and because we cannot rule it out at this time, we are reporting this event due to the 30-day reporting deadline.If we become aware of additional information, we will supplement this report.The submission of this report is not an admission that the device caused or contributed to the reported event.

Event Description

Patient was a (b)(6) who underwent a repeat c-section.There were no complications with the surgery.Her fundus was firm at the time of transfer to the post anesthesia care unit.The md was notified approximately 1.5 hours later by the nurse that the patient was not making very much urine.When physician checked her bleeding, she noticed clots in her vagina.Her fundus felt firm, however, the lower uterine segment was not firm and uterotonics were given (unknown which ones were administered).Jada was placed under ultrasound guidance.The md immediately noticed that the suction was not working.After several minutes it appeared that the suction was working "some" and blood was noted in the jada tube.Md stated her cervix was very anterior, about 6-7cm.The patient was later checked again after changing positions and there were clots noted behind the jada cervical seal.The patient was taken to the or and clots were cleared.There was no evidence of retained placenta.Clots were removed from jada and flushed with sterile fluid by the md.Jada was then placed again and attached to regulated wall suction.Md noted that the wall suction was very far away from the patient and up high on the wall.When attached, md stated the suction was again not working.Md hooked jada up to anesthesia's suction and it worked well, however, md did not feel safe having the suction attached to an unregulated source.Jada was then removed, and bakri attempted.Bakri slipped out immediately and patient was treated with more uterotonics and stabilized.Md stated that jada did not cause any injury to the patient or escalation of care.

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ALYDIA HEALTH; 3495 edison way; menlo park CA 94025
• Manufacturer (Section G): ALYDIA HEALTH; 3495 edison way; menlo park CA 94025
• Manufacturer Contact: richard ferrick ; 3495 edison way; menlo park, CA 94025 ; 8445232666
• MDR Report Key: 11566368
• MDR Text Key: 254979322
• Report Number: 3017425145-2021-00007
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Device Lot Number: 1037501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 79