MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-03 for DEROYAL M2100-SL manufactured by Rondish Company Limited.
[132924436]
A call/complaint was received indicating the "patient slid to the floor and the alarm did not sound". There were no injury reported. The work order could not be reviewed because the finished good lot number was not reported. The sample was received and evaluated by quality control. A supplier corrective action request (scar) has been issued to the manufacturing facility. The sample has been returned to the manufacturing facility for further examination. This investigation is ongoing at this time. We will provide a follow up report when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[132924437]
Quality issue details. Date of occurrence: (b)(6) 2018. When did quality issue occur? During use. Who was using or operating the product when the quality issue occurred? Health professional. Was a medical procedure involved? No. Name of medical procedure: not applicable, did the quality issue cause a delay in the medical procedure? Not applicable. Detailed description of quality issue: the alarm was used for a patient and the rn reported using the normal process. The patient slid to the floor and the alarm did not sound. When the alarm was tested later it seemed to work appropriately. The rn is certain that the alarm had been properly set and had malfunctioned. How was the quality issue was identified? By actual use. How was the product being used? Used to monitor patients at risk of falling out of the chair. Was it the initial use of the product? No. Was the product modified from the original condition supplied by deroyal? No. Was the product connected to or used in conjunction with other devices or equipment? Yes. Please describe connected equipment type, settings, etc. : used with our chair sensor (m2200-cp) has the end user notified the manufacturer of the other devices used in conjunction with or connected to the product? Yes. Outcome details. Outcome(s) attributed to quality issue: none. Person(s) affected by outcome(s) checked above: none. Known pre-existing condition(s) of person(s) affected: none. Was the incident reported to the fda? No. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: none.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2018-00011 |
| MDR Report Key | 8212375 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-03 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-12-05 |
| Date Mfgr Received | 2018-12-07 |
| Date Added to Maude | 2019-01-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MELISSA LOGSDON |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626157 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1703 HWY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | BED PATIENT MONITOR |
| Product Code | KMI |
| Date Received | 2019-01-03 |
| Returned To Mfg | 2018-12-17 |
| Model Number | M2100-SL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RONDISH COMPANY LIMITED |
| Manufacturer Address | UNIT G & H,4/F, BLK 1 15-33 KWAI TAK ST. KAWI CHUNG NT, CHINA HK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-03 |