MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for AUTOCLAVABLE INTERNAL HANDLES 1003-0143-04 manufactured by Zoll Medical Corporation.
[133459391]
Please refer to the attached user medwatch report that zoll medical has received. Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation. [(b)(4) medwatchreport__. Pdf]
Patient Sequence No: 1, Text Type: N, H10
[133459392]
Complainant alleged that while attempting to defibrillate a one year old female patient at five joules, the device only discharged one joule. Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[134094425]
The customer was contacted for return of the suspect product. The customer has responded and indicated the product will not be returning to zoll.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2019-00056 |
| MDR Report Key | 8258522 |
| Date Received | 2019-01-17 |
| Date of Report | 2018-12-28 |
| Date of Event | 2018-07-23 |
| Date Mfgr Received | 2018-12-28 |
| Date Added to Maude | 2019-01-17 |
| 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 Street | 269 MILL ROAD |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal | 01824 |
| Manufacturer Phone | 9784219552 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOCLAVABLE INTERNAL HANDLES |
| Generic Name | INTERNAL HANDLES |
| Product Code | LDD |
| Date Received | 2019-01-17 |
| Model Number | 1003-0143-04 |
| Catalog Number | 1003-0143-04 |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Manufacturer Address | 269 MILL ROAD CHELMSFORD MA 01824 US 01824 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-17 |