MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-01-31 for ASCOM TELLIGENCE 3.2 NGTELL32-S manufactured by Ascom (sweden) Ab.
[66161127]
While the site requested help with the history logs and reports from mdds system telergy, our investigation focused on the reported patient death approximately 15 hours after the reported bed exit and fall, and the performance of the ascom telligence nurse call system the hospital staff reported that the nurse call system performed as designed. That is, it detected and annunciated the bed exit condition to the staff. Our investigation included a review of the logs and reports of the event from (b)(4) staff including clinical engineering an quality. Device is a hardwired nurse call system.
Patient Sequence No: 1, Text Type: N, H10
[66161128]
Reported under ascom ticket (b)(4): on (b)(4) a patient fell in the room, and subsequently died. Site attempting to collect data from reports for a bed exit. There are sporadic issues with missing data from the reports. Site wants help with reports from telergy and pc reporting with respect to this time frame. The patient was in a hillrom bed with a hillrom bed exit sensor-part number p3200a000011. The bed / bed exit sensor was connected to ascom telligence nurse call patient station. Ascom tech support specialist (b)(6) spoke with (b)(6) from the hospital clinical engineering department on (b)(6) 2016. (b)(6) advised that the bed exit sensor was placed properly and had been working the previous day. In a follow-up call on (b)(6) 2016, (b)(6) advised that the nurses responded to a bed exit alarm at the staff console and that was the reason why there were 5 nurses in the room around 03:50am. On (b)(6) 2016 (b)(6) attempted to contact (b)(6) hospital, at (b)(6). Her voicemail message indicated that she would be out of the office until monday (b)(6) 2016. She left an alternate contact number at (b)(6). I called this number and spoke to (b)(6), also with the quality department. I explained to ms. (b)(6) that we had received information about a potential adverse event at (b)(6) on (b)(6) between midnight and 4:00 am on the medical unit (b)(6). She looked up the case in question. She confirmed there was an incident on that date. Ms. (b)(6) was able to tell me that on (b)(6) at 3:50 am the staff heard a loud thud, simultaneous with a bed alarm in room (b)(6). The female patient in that room had gotten out of bed and fallen. Medical records indicated a scalp laceration to the right side of the head, and ecchymosis to the left eye. The scalp laceration was sutured in the room, and a subsequent ct was performed and came back okay. The patient was on neuro checks throughout the day, and her condition remained unchanged. At 18:45 on (b)(6) 2016 the patient reported difficulty in breathing and subsequently expired. The event was reported to us by our distributor, (b)(4), see section e, initial reporter, the site name is (b)(6) hospital, (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005334549-2016-00001 |
| MDR Report Key | 6289792 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-30 |
| Date of Event | 2016-10-07 |
| Date Mfgr Received | 2016-10-21 |
| Date Added to Maude | 2017-01-31 |
| 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 |
| 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 SUITE 100 |
| Manufacturer City | BRADENTON FL 34202 |
| Manufacturer Country | US |
| Manufacturer Postal | 34202 |
| Manufacturer Phone | 9416845497 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASCOM |
| Generic Name | TELLIGENCE NURSE CALL SYSTEM |
| Product Code | IQA |
| Date Received | 2017-01-31 |
| Model Number | TELLIGENCE 3.2 |
| Catalog Number | NGTELL32-S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCOM (SWEDEN) AB |
| Manufacturer Address | GRIMBODALEN 2 GOTEBORG, SE-O SE-41749 SW SE-41749 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2017-01-31 |