MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-01 for STANLEY HEALTHCARE M200 manufactured by Stanley Security Solutions.
[109903511]
(b)(4) -- m200 alarm not sounding (was received today, and evaluated) (ship date 7/28/2016) mw5077239 capa-(b)(4) created. M200 visual inspection: three batteries returned. Voltages for all at 2. 942v which is below nominal, but unit will still function. Pad 1 jack has damaged retention tabs tape residue around pad1 and pad2 areas m200 power on function test per (b)(4). Pad 1 jack gives positive tone on pad insertion and positive arming tone after 4 seconds of pad pressure pad 2 jack gives positive tone on pad insertion and positive arming tone after 4 seconds of pad pressure all switches and buttons function properly as per instruction manual. All tones and volumes function. Tones are outdated and need update recorded voice plays back at nominal volume and clarity. Tested nurse-call jack, operations were nominal.
Patient Sequence No: 1, Text Type: N, H10
[109903512]
Patient heard to be moaning and rn found patien on the floor in front of the chair. Patient on chair alarm that did not sound. Chair alarm and chair pad replaced. Noted to have been a malfunction of the chair alarm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1929691-2018-00004 |
| MDR Report Key | 7562902 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-01 |
| Date of Report | 2018-05-11 |
| Date of Event | 2018-05-10 |
| Date Facility Aware | 2018-05-10 |
| Report Date | 2018-05-11 |
| Date Reported to FDA | 2018-05-11 |
| Date Reported to Mfgr | 2018-05-23 |
| Date Mfgr Received | 2018-05-14 |
| Device Manufacturer Date | 2018-07-28 |
| Date Added to Maude | 2018-06-01 |
| 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 | MS GINA BENNETT |
| Manufacturer Street | 4600 VINE STREET |
| Manufacturer City | LINCOLN NE 68506 |
| Manufacturer Country | US |
| Manufacturer Postal | 68506 |
| Manufacturer G1 | STANLEY SECURITY SOLUTIONS |
| Manufacturer Street | 4600 VINE STREET |
| Manufacturer City | LINCOLN NE 68506 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68506 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANLEY HEALTHCARE |
| Generic Name | M200 |
| Product Code | KMI |
| Date Received | 2018-06-01 |
| Returned To Mfg | 2018-05-15 |
| Model Number | M200 |
| Catalog Number | M200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY SECURITY SOLUTIONS |
| Manufacturer Address | 4600 VINE STREET LINCOLN NE 68503 US 68503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-06-01 |