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

Model Number JADA - 1001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/20/2022

Event Type  Injury  

Event Description

Alydia health received a completed jada experience survey form that reported jada did not stop the postpartum hemorrhage (pph) and noted, "manual massage, all meds" in the area on the survey designated for feedback when 'jada did not stop bleeding'.The event date for this survey was noted as (b)(6) 2022, and the survey was received by alydia health on february 4, 2022.This patient is described as having prior pph.Her current pph started within one hour after a spontaneous vaginal delivery.Prior to jada use she received unknown doses of hemabate, cytotec, methergine, and txa.The patient's blood loss prior to jada use was reported as 1950 ml, which is severe pph.There are additional handwritten notes on the jada experience survey that the "suction was hooked up but did not work - jada in for only one minute then removed." the handwritten note also states, "suction worked for 10 seconds then stopped (120mmhg).Provider did not deflate balloon before start (not sure if this was user error).Doctor reported suction needed to be at 120 mmhg, so rn turned it up to 120.When i went in and stated a max of 90 mmhg, turned down, didn't work." the information provided for this event was received from the survey and is very limited in detail.Follow up request made for further information (including lot number and if the device was retained) on february 9, 2022.Additional information was provided for this case via email on february 9, 2022, from caitlin gravina.The staff issues with this case "did not have to do with jada", the staff made an error and utilized neonatal suction, which was the wrong suction.They did not trouble shoot or attempt to use another device.The site discarded the jada that they attempted to use and did not record the lot number for this case.A good faith effort to obtain lot number has been attempted.They declined to provide any additional information for this case.

Manufacturer Narrative

Based on the overall information currently available for this report, a possible contributing or causal role of the jada system to the need for additional treatments (reported as manual massage and unspecified meds) to preclude permanent body damage/impairment cannot be excluded.Based on the overall information currently available in this report, there is no clear evidence at this time that a malfunction occurred with the jada system as the case is confounded by possible user error (reported as "provider did not deflate balloon before start [not sure if this was user error].Doctor reported suction needed to be at 120 mmhg, so rn turned it up to 120.").Per the jada system ifu (troubleshooting) "check connection on all system components" and "confirm vacuum tubing is securely connected at both ends and any connection in between", "" 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."" , "remove air from cervical seal prior to device use to minimize risk of air embolism if cervical seal bursts", "the maximum vacuum pressure is 90 mm hg.Do not increase the vacuum pressure higher than 90 mm hg.", per jada preparation steps: ""use a sterile luer tapered syringe to remove any air that is in the cervical seal."" and ""fill sterile luer tapered syringe with 60 ml of sterile fluid."" out of an abundance of caution, the company will report this case as a serious injury mdr.

• 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: heather wisler ; 3495 edison way; menlo park, CA 94025 ; 8445232666
• MDR Report Key: 13669860
• MDR Text Key: 291395180
• Report Number: 3017425145-2022-00024
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JADA - 1001
• Device Catalogue Number: JADA-1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 30 YR
• Patient Sex: Female