MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-10 for STANLLEY HEALTHCARE 73030 manufactured by Stanley Healthcare.
[119786412]
On september 7, 2018: (b)(6). (b)(4). Dear (b)(6), on 4/24/2018, stanley healthcare (sh) received a medwatch report from your facility reporting device malfunctions. You reported an incident having occurred on (b)(6) 2018. Report indicates the patient was subsequently transferred to higher level care, and that the results revealed acute bilateral subarachnoid hemorrhage. To date, none of the reported equipment has been returned to sh for further evaluation as requested. We last spoke 7/27/2018 at 1:28 pm cst. Several other attempts have been made to contact you, the last being 8/31/2018 wherein i left a voicemail with (b)(6). As my calls and emails have not been returned - i am closing out this filing citing no further action required by stanley healthcare. The testing operation defined on page 20 of the user manual outlines the proper testing protocol to be used when arming the m200 fall monitor. If you have any questions, please feel free to contact me at (b)(4). Sincerely, (b)(4), sr. Quality, ehs and compliance manager, stanley healthcare. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119786413]
Patient was found on floor by staff. Patient has been placed in geriatric chair with chair alarm pad underneath patient. Chair alarm did not alarm when patient exited chair unassisted. Staff responded. Upon inspection of the chair alarm, chair pad was not functioning properly. ...
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1929691-2018-00008 |
| MDR Report Key | 7861857 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-10 |
| Date of Report | 2018-04-04 |
| Date of Event | 2018-03-29 |
| Report Date | 2018-04-04 |
| Date Reported to FDA | 2018-04-04 |
| Date Reported to Mfgr | 2018-04-04 |
| Date Mfgr Received | 2018-04-24 |
| Device Manufacturer Date | 2017-06-15 |
| Date Added to Maude | 2018-09-10 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR GARTH JACK |
| Manufacturer Street | 4600 VINE STREET |
| Manufacturer City | LINCOLN NE 68503 |
| Manufacturer Country | US |
| Manufacturer Postal | 68503 |
| Manufacturer Phone | 4027429335 |
| Manufacturer G1 | STANLEY HEALTHCARE |
| Manufacturer Street | 4600 VINE STREET |
| Manufacturer City | LINCOLN NE 68503 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68503 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANLLEY HEALTHCARE |
| Generic Name | MONITOR BED PATIENT |
| Product Code | KMI |
| Date Received | 2018-09-10 |
| Model Number | 73030 |
| Catalog Number | 73030 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY HEALTHCARE |
| Manufacturer Address | 4600 VINE STREET LINCOLN NE 68503 US 68503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2018-09-10 |