MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-920PA

Model Number ZM-920PA

Device Problems Overheating of Device (1437); Radio Signal Problem (1511); Failure to Transmit Record (1521); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter will sometimes overheat and will stop transmitting on the central nurses station (cns).No patient harm was reported.Transmitter was swapped out with a working transmitter.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Event Description

The customer reported that the transmitter will sometimes overheat and will stop transmitting on the central nurses station (cns).No patient harm was reported.

Manufacturer Narrative

Corrected data: (b)(4).Manufacturer narrative: the biomedical engineer reported that the transmitter sometimes overheated and would stop transmitting to the central nurses station (cns).No patient harm was reported.The transmitter was swapped out with a known working one.No evaluation was done on the failed device, as it was never returned to nihon kohden.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Manufacturer Narrative

Corrected data: additional manufacturer narrative.Additional information: c.Suspect products, type of report: follow up, type of report, follow up, additional information/correction.The biomedical engineer reported that the transmitter sometimes overheated and would stop transmitting to the central nurses station (cns).No patient harm was reported.The transmitter was swapped out with a known working one.No evaluation was done on the failed device, as it was never returned to nihon kohden.Per (b)(4) this complaint can be closed because transmitter overheating stemming from an incorrect battery installation has been addressed with technical bulletins (b)(4).

• Brand Name: ZM-920PA
• Type of Device: ZM-920PA
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; attn: shama mooman; tomioka city, gunma 370-2 343; JA 370-2343
• Manufacturer Contact: shama mooman ; 1-1 tajino; attn: shama mooman; tomioka city, gunma 370-2-314 ; JA 370-2314 ; 2687488
• MDR Report Key: 6483199
• MDR Text Key: 72782723
• Report Number: 8030229-2017-00103
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2017,03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-920PA
• Device Catalogue Number: ZM-920PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 04/11/2017
• Distributor Facility Aware Date: 03/17/2017
• Device Age: 86 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2017
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other