MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-22 for PUMP BASIC RACK MOBILE VERSION 0710001 manufactured by Medela Ag.
[176223753]
The device was returned and evaluated on 11/18/2019 by medela ag. During the evaluation of the exterior of the device, no damage or deformation was noted. Additionally, the device powered on without issue and, during a 5 minute running test, the device ran normally and within vacuum specifications. Refer to attached test protocol. It is possible that the hospital used the device incorrectly because the device had been checked with the service department at the hospital and the pressure was correct. The hospital chose not to provide detailed information; therefore, no further information was able to be obtained regarding the patient's backgrounds and the device usage/management methods. Additionally, the extent or cause of the injuries was unable to be identified. Although it cannot be confirmed that the basic device caused or contributed to the patient's injuries, medela is filing this report.
Patient Sequence No: 1, Text Type: N, H10
[176223754]
On 10/20/2019, a healthcare professional from centro medico teknon alleged to medela spain that in the past two months, three babies had suffered injuries during a procedure using the basic medical suction pump.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419937-2020-00003 |
| MDR Report Key | 9615909 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-22 |
| Date of Event | 2019-08-20 |
| Date Mfgr Received | 2019-10-20 |
| Device Manufacturer Date | 2011-11-02 |
| Date Added to Maude | 2020-01-22 |
| 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 | JAN KLOIBER |
| Manufacturer Street | 1101 CORPORATE DRIVE |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer Phone | 8004358316 |
| Manufacturer G1 | MEDELA AG |
| Manufacturer Street | LATTICHSTRASSE 4B |
| Manufacturer City | BAAR ZUG, 6341 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUMP BASIC RACK MOBILE VERSION |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2020-01-22 |
| Returned To Mfg | 2019-11-18 |
| Model Number | 0710001 |
| Catalog Number | 0710001 |
| Lot Number | NA |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA AG |
| Manufacturer Address | LATTICHSTRASSE 4B BAAR ZUG, 6341 SZ 6341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-22 |