MAUDE Adverse Event Report: AIRLIFE OY VITAL SIGNS; FETAL SPIRAL ELECTRODE FOR COROMETRICS

Model Number	7000AAO
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: electrode (fetal spiral) the product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 26 novt 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by sunmed holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to sunmed holdings llc.Sunmed holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sunmed holdings complaint database and is identified as complaint - (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a sunmed holdings llc.Product is defective or causes serious injury.
Event or Problem Description
It was reported that "spiral fetal electrode being left inside a patient following delivery.It (part of fse) was left inside the mother following a c section delivery, it was disconnected from the baby, the baby was ok and was delivered.It happened during a [?]swab', the part of the fse was shifted and pushed further up into the mum.They had disconnected the fse from the baby, had cut the wire and that part was left inside the mum".
Additional Manufacturer Narrative
H6: electrode (fetal spiral).The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 26 novt 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by sunmed holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to sunmed holdings llc.Sunmed holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sunmed holdings complaint database and is identified as complaint - (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a sunmed holdings llc.Product is defective or causes serious injury.The complaint of spiral fetal electrode being left inside a patient following delivery.- it (part of fse) was left inside the mother following a c section delivery, it was disconnected from the baby, the baby was ok and was delivered.It happened during a swab', the part of the fse was shifted and pushed further up into the mum.They had disconnected the fse from the baby, had cut the wire and that part was left inside the mum.See pic.Regarding part 7000aao fetal scalp electrode.Was confirmed via photo analysis and event description.The root cause was determined and could possibly be a result of use error.A risk assessment was performed and the ultimate risk was determined to be medium which does not require the initiation of a capa.Issue was escalated to helsinki carb as (b)(4).There have been zero other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
It was reported that "spiral fetal electrode being left inside a patient following delivery.It (part of fse) was left inside the mother following a c section delivery, it was disconnected from the baby, the baby was ok and was delivered.It happened during a swab', the part of the fse was shifted and pushed further up into the mum.They had disconnected the fse from the baby, had cut the wire and that part was left inside the mum".

• Brand Name: VITAL SIGNS
• Common Device Name: FETAL SPIRAL ELECTRODE FOR COROMETRICS
• Manufacturer (Section D): AIRLIFE OY; kuortaneenkatu 2; helsinki uusimaa, fl FIN-0 0510; FI FIN-00510
• Manufacturer (Section G): AIRLIFE OY; kuortaneenkatu 2; helsinki uusimaa, fl FIN-0 0510; FI FIN-00510
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 20793826
• Report Number: 3010838917-2024-00209
• Device Sequence Number: 20781292
• Product Code: HGP
• UDI-Device Identifier: 10190752142176
• UDI-Public: (01)10190752142176
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 7000AAO
• Device Catalogue Number: 7000AAO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown