MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-20 for ASCOM MOBILE MONITORING GATEWAY (MMG) SW000400 NOT APPLICABLE manufactured by Ascom Sweden Ab.
[117689948]
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.
Patient Sequence No: 1, Text Type: N, H10
[117689949]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008952681-2018-00001 |
| MDR Report Key | 7800071 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-20 |
| Date of Report | 2018-08-19 |
| Date of Event | 2018-07-16 |
| Date Mfgr Received | 2018-07-19 |
| Device Manufacturer Date | 2015-09-09 |
| Date Added to Maude | 2018-08-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHRISTOPHER WOOD |
| Manufacturer Street | 9024 TOWN CENTER PARKWAY |
| Manufacturer City | BRADENTON FL 34202 |
| Manufacturer Country | US |
| Manufacturer Postal | 34202 |
| Manufacturer Phone | 9416845497 |
| Manufacturer G1 | ASCOM SWEDEN AB |
| Manufacturer Street | GRIMBODALEN 2 |
| Manufacturer City | GOTEBORG, VASTRA GOTALANDS LAN [SE-14] SE-41749 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-41749 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASCOM MOBILE MONITORING GATEWAY (MMG) |
| Generic Name | NETWORK AND COMMUNICATION MIDDLEWARE |
| Product Code | MSX |
| Date Received | 2018-08-20 |
| Model Number | SW000400 |
| Catalog Number | NOT APPLICABLE |
| Lot Number | NOT APPLICABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCOM SWEDEN AB |
| Manufacturer Address | GRIMBODALEN 2 GOTEBORG, VASTRA GOTALANDS LAN [SE-14] SE-41749 SW SE-41749 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-08-20 |