MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-15 for MONARCH MODEL 1000 ACS - LTE PMACS1LT manufactured by Hill-rom Singapore.
[123753544]
The use of the monarch system, combined with the patient's underlying pathology and medication, may have contributed to her fractured ribs. The patient did not allege the device malfunctioned. The patient returned the device to hill-rom. The investigation is ongoing. However, if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[123753545]
Hill-rom received a report from the account stating the patient felt pain in her back after the monarch system treatment. She then heard a pop and the sound of paper tearing. She was taken to the emergency room where they found ribs #8 & 9 on her right side were fractured. The device was located at the patient's home. This report was filed in our complaint handling system as complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2018-00004 |
| MDR Report Key | 7966892 |
| Report Source | CONSUMER |
| Date Received | 2018-10-15 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-09-14 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2018-05-09 |
| Date Added to Maude | 2018-10-15 |
| 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 | LORI DAULTON |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONARCH MODEL 1000 ACS - LTE |
| Generic Name | PERCUSSOR, POWERED-ELECTRIC |
| Product Code | BYI |
| Date Received | 2018-10-15 |
| Model Number | PMACS1LT |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM SINGAPORE |
| Manufacturer Address | 1 YISHUN AVENUE 7 SINGAPORE, NORTH EAST 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-15 |