MAUDE Adverse Event Report: ASCOM SWEDEN AB ASCOM MOBILE MONITORING GATEWAY (MMG); NETWORK AND COMMUNICATION MIDDLEWARE

Model Number	SW000400
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/16/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The conclusion based on the log analysis is that the mmg has operated as intended (i.E.No malfunction).Alarm notifications have been distributed to one handset that was assigned.The mmg has been used improperly in the sense that the escalation levels 2 and 3 were not assigned by the user facility to any other handset.We requested from the user facility a confirmation whether the mmg has caused or contributed to the event, and also additional log information prior to the event to determine if there were similar issues prior to this event.We decided to report this event as a potential use error under 21 cfr 803 because we cannot, based on the information, rule out that the product has contributed to the adverse event.We have not been able to obtain from a qualified person a medical judgment that a device did not cause or contribute to the adverse event.
Event or Problem Description
As reported to ascom (us) inc., in customer complaint ticket (b)(4): on monday (b)(6) 2018 an asystole alarm went out to the handset defined as level 1.The nursing staff said that they did not get the alarm for 4-5 minutes.(b)(6), biomed at the user facility ((b)(6) medical center), mentioned that he saw that only one level (level 1) was assigned in the system when he checked.He also said that the patient died but that no event occurred, because the female patient was sick.The user facility asked ascom to investigate the log files.

• Brand Name: ASCOM MOBILE MONITORING GATEWAY (MMG)
• Common Device Name: NETWORK AND COMMUNICATION MIDDLEWARE
• Manufacturer (Section D): ASCOM SWEDEN AB; grimbodalen 2; goteborg, vastra gotalands lan [se-14] SE-41 749; SW SE-41749
• MDR Report Key: 7800071
• Report Number: 3008952681-2018-00001
• Device Sequence Number: 11156426
• Product Code: MSX
• UDI-Device Identifier: 17350088670009
• UDI-Public: (01)17350088670009(10)V4.2.0(11)150909
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SW000400
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death